Alan Cormier has over 10 years of experience in medical and biotechnology manufacturing. He has a strong background in quality control, production processes, and FDA compliance. He is skilled in process development, purification systems, equipment operation and maintenance, and training technicians. Cormier seeks a leadership position where he can utilize his expertise in cGMP manufacturing.
M. Sukumar has over 20 years of experience in the pharmaceutical industry, currently serving as the AGM of Production at Strides Shasun Pharmaceutical Pvt Ltd in Cuddalore, Tamil Nadu. He previously held leadership roles at Acebright India Pharmachem Pvt Ltd in Bangalore and other companies. Sukumar has extensive experience in API manufacturing, process development, quality management, regulatory compliance, and project management. He has led facilities and production teams, and achieved success in USFDA, WHO, and customer audits.
The document discusses regulations governing Good Manufacturing Practices (GMP). It aims to provide an understanding of GMP regulations and their application and interpretation. The key GMP regulations cover the drug, medical device, food, and blood industries. GMP regulations provide flexibility for manufacturers but can also lead to confusion in interpretation. Subparts cover organization and personnel qualifications, facilities and equipment requirements, material and component controls, production and process controls, and documentation.
The document discusses production and scale-up techniques for suspensions and emulsions. It explains that while a drug product may be successfully developed in a small research laboratory setting, scaling up to large commercial production introduces many challenges. To address this, pharmaceutical companies use pilot plants which allow experimental formulations to be transferred from the laboratory to commercial-scale production. This helps identify and resolve potential problems before full-scale manufacturing. The document then describes various aspects of pilot plant facilities including their functions, organizational structures, staffing needs and training requirements.
Kabe Lantry has over 10 years of experience working in laboratory services and biotechnology. Their experience includes laboratory hygiene, aseptic technique, quality control, inventory management, and equipment operation. They currently work as a Laboratory Services Technician at Amgen where they help ensure GMP compliance and minimize delays.
GMP & Quality Assurance Training by Fakultas Farmasi Universitas AndalasAtlantic Training, LLC.
GMP and quality assurance systems ensure that products are consistently manufactured and controlled according to quality standards for their intended use. QA encompasses all aspects that influence quality, including GMP and quality control. GMP specifies the production and control procedures that need to be followed. QC, as part of GMP, covers sampling, testing, and release of products to ensure the necessary tests are conducted and products meet specifications before release. Together, QA, GMP and QC work to build quality into every aspect of production from start to finish.
Unit 2 organization and personnel and permisies himanshuhimanshu kamboj
pharmaceutical quality assurance
b pharma 6th sem
Personnel objectives
Personnel qualifications
Personnel responsibilities
Key personnel
Responsibilities of the head of the production department
Responsibilities of the head of quality control department
Training
Personnel hygiene
Premises
Layout of pharmaceutical industry
Areas of premises
Environmental control in sterile areas
Equipment and raw materials
Stages of equipment
Cleaning and maintenance
Raw materials
Steps involved in purchase procedure
Maintenance of stores
Storage conditions
The document discusses the divine journey of advancing aseptic technology through blow-fill-seal (BFS) processes. It describes how BFS is considered an advanced aseptic technology due to its automated and enclosed design that prevents human intervention. BFS embraces quality-by-design principles by simplifying manufacturing through automation and reducing variables. The closed equipment design, uniform extrusion and sealing, and control of materials and air ensure robust container integrity and compliance with validation requirements. Continued process verification further protects consumers and ensures product quality remains within limits. Retrofitting BFS equipment has provided benefits like reduced costs, improved yields, and an enhanced product portfolio.
This document is a resume for Mark Quinton. It summarizes his work experience as a Process Supervisor and Operator for Medtronic in Galway and UCB Schwarz Pharma in Shannon, as well as a General Shift Supervisor role at Fabricated Products in Shannon. It outlines his responsibilities and skills in each role, with a focus on ensuring quality production in regulated environments. His education and training background is also summarized.
M. Sukumar has over 20 years of experience in the pharmaceutical industry, currently serving as the AGM of Production at Strides Shasun Pharmaceutical Pvt Ltd in Cuddalore, Tamil Nadu. He previously held leadership roles at Acebright India Pharmachem Pvt Ltd in Bangalore and other companies. Sukumar has extensive experience in API manufacturing, process development, quality management, regulatory compliance, and project management. He has led facilities and production teams, and achieved success in USFDA, WHO, and customer audits.
The document discusses regulations governing Good Manufacturing Practices (GMP). It aims to provide an understanding of GMP regulations and their application and interpretation. The key GMP regulations cover the drug, medical device, food, and blood industries. GMP regulations provide flexibility for manufacturers but can also lead to confusion in interpretation. Subparts cover organization and personnel qualifications, facilities and equipment requirements, material and component controls, production and process controls, and documentation.
The document discusses production and scale-up techniques for suspensions and emulsions. It explains that while a drug product may be successfully developed in a small research laboratory setting, scaling up to large commercial production introduces many challenges. To address this, pharmaceutical companies use pilot plants which allow experimental formulations to be transferred from the laboratory to commercial-scale production. This helps identify and resolve potential problems before full-scale manufacturing. The document then describes various aspects of pilot plant facilities including their functions, organizational structures, staffing needs and training requirements.
Kabe Lantry has over 10 years of experience working in laboratory services and biotechnology. Their experience includes laboratory hygiene, aseptic technique, quality control, inventory management, and equipment operation. They currently work as a Laboratory Services Technician at Amgen where they help ensure GMP compliance and minimize delays.
GMP & Quality Assurance Training by Fakultas Farmasi Universitas AndalasAtlantic Training, LLC.
GMP and quality assurance systems ensure that products are consistently manufactured and controlled according to quality standards for their intended use. QA encompasses all aspects that influence quality, including GMP and quality control. GMP specifies the production and control procedures that need to be followed. QC, as part of GMP, covers sampling, testing, and release of products to ensure the necessary tests are conducted and products meet specifications before release. Together, QA, GMP and QC work to build quality into every aspect of production from start to finish.
Unit 2 organization and personnel and permisies himanshuhimanshu kamboj
pharmaceutical quality assurance
b pharma 6th sem
Personnel objectives
Personnel qualifications
Personnel responsibilities
Key personnel
Responsibilities of the head of the production department
Responsibilities of the head of quality control department
Training
Personnel hygiene
Premises
Layout of pharmaceutical industry
Areas of premises
Environmental control in sterile areas
Equipment and raw materials
Stages of equipment
Cleaning and maintenance
Raw materials
Steps involved in purchase procedure
Maintenance of stores
Storage conditions
The document discusses the divine journey of advancing aseptic technology through blow-fill-seal (BFS) processes. It describes how BFS is considered an advanced aseptic technology due to its automated and enclosed design that prevents human intervention. BFS embraces quality-by-design principles by simplifying manufacturing through automation and reducing variables. The closed equipment design, uniform extrusion and sealing, and control of materials and air ensure robust container integrity and compliance with validation requirements. Continued process verification further protects consumers and ensures product quality remains within limits. Retrofitting BFS equipment has provided benefits like reduced costs, improved yields, and an enhanced product portfolio.
This document is a resume for Mark Quinton. It summarizes his work experience as a Process Supervisor and Operator for Medtronic in Galway and UCB Schwarz Pharma in Shannon, as well as a General Shift Supervisor role at Fabricated Products in Shannon. It outlines his responsibilities and skills in each role, with a focus on ensuring quality production in regulated environments. His education and training background is also summarized.
Jonathan K. Mentzer has over 25 years of experience in quality assurance and quality control roles. He has a proven track record of reducing customer complaints and internal quality issues through root cause analysis. His experience includes setting up quality systems, conducting audits, developing testing protocols, and ensuring regulatory compliance. Currently he works as a Quality Assurance Coordinator at Frutarom USA overseeing quality for multiple divisions.
Dr. Alok Kumar Sharma has over 23 years of experience in manufacturing operations and quality assurance in the pharmaceutical bulk drugs industry. He holds a PhD in Organic Chemistry and has worked in leadership roles at several companies, currently serving as Vice President at Kores India Ltd. He has expertise in production planning, quality management, process optimization, and commissioning new plants and products.
Experienced, results-oriented professional with broad experience in pharmaceutical quality processes and problem solving. Expertise in reviewing complaints, SOPs, Batch Records, and other documentation for accuracy and completeness. Skilled in preparing for internal or external audits and correcting deficiencies. Demonstrated ability to bring new facilities into FDA compliance. Proficient in SAP and Trackwise. Areas of expertise:
PQMS | Batch Record Review | Controlled Substances | Document Control
FDA Regulations | Metrics Reporting | GMP / GLP, OSHA
Albert Brantley Jr. has over 30 years of experience in quality assurance and production roles in the pharmaceutical and chemical industries. His experience includes writing validation protocols and standard operating procedures, performing audits, developing quality systems, and managing production. He currently works as a Quality Engineer for Paxico LLC where he leads validation and compliance activities.
The document discusses the role of quality assurance (QA) in the pharmaceutical industry. QA acts as key personnel to ensure customer safety, product quality, and efficacy. QA is involved throughout the product life cycle, from design and development by authorizing documents, evaluating and auditing vendors, to manufacturing through environmental monitoring, calibration, and validation. In post-production, QA oversees stability testing, sample retention, product complaints, and recalls. QA also ensures compliance through activities like change control, deviation handling, audits, and documentation. The overall goals are to build quality into products and make quality the responsibility of all involved in manufacturing.
M. Srinivasan is an experienced Operations Manager with over 18 years of experience in pharmaceutical manufacturing. He has a strong background in production planning and quality assurance. Srinivasan is looking for new opportunities to utilize his skills in operations management, process improvement, quality audits, and machinery maintenance. He has worked for several major pharmaceutical companies and has experience managing facilities, projects, and over 400 employees.
Pilot Plant Scale Up Techniques Used in Pharmaceutical Manufacturing, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgaum/Belagavi
This document provides information on standard operating procedures (SOPs) for manufacturing equipment used in liquid, solid, and semi-solid dosage forms. It discusses what an SOP is, the objectives and benefits of SOPs, types of SOPs, SOP writing style, important points to consider when writing SOPs, and common equipment used to prepare liquid and semi-solid formulations. The document emphasizes that SOPs are essential for ensuring consistent, compliant production operations and for training personnel. They help maintain quality control and assure regulatory compliance.
Quality Assurance Services, Inc. provides quality assurance services including receiving inspection, containment, sorting, inspection, rework, repair, and warehousing for customers. Its mission is to be a successful supplier committed to continuous improvement, customer satisfaction, employee development, long-term partnerships, growth and profitability. It aims to be the industry leader in quality services through strategic partnerships. The company orients its processes around customer requirements and satisfaction through effective inspection, containment of non-conforming products, and meeting production schedules.
The document discusses quality control in manufacturing. It explains that quality control aims to maintain standards and provide feedback to improve future production by minimizing defects. Quality inspection checks for defects but does not provide this feedback. Quality assurance focuses on systems and documentation to avoid issues before production begins. For highest quality, companies should collectively apply quality inspection, quality control, and quality assurance. The document also defines quality costs and categorizes them as prevention, appraisal, internal failure, and external failure costs.
This document discusses pilot plant scale up in the pharmaceutical industry. It defines a pilot plant as transforming a lab scale formula into a viable product through developing a reliable manufacturing process. Conducting pilot plant studies is important as effects of large scale production cannot be predicted from lab data alone. A pilot plant allows investigating products and processes on an intermediate scale before full production. It permits examining formulas' ability to withstand scale changes and modifying equipment, materials, and production rates. The document outlines pilot plant design, operations including validation, training, engineering support, maintenance, quality assurance, and quality control. The significance of a pilot plant is to refine formulas and determine equipment and materials that can consistently meet specifications for reliable manufacturing.
This document discusses personnel validation in the pharmaceutical industry. It covers the need for personnel validation to ensure qualified employees are appropriately trained. Key areas discussed include personnel responsibilities, training requirements and methods, gowning procedures, standard operating procedures, and regulatory guidelines around personnel qualification from organizations like WHO and FDA. The goal of personnel validation is to demonstrate personnel are qualified and aware of their responsibilities to ensure product quality.
Gmp (q7 ich guide) & Stem cells-based therapy product manufacturingM. Agung Sumantri
This document provides a summary of key points from the ICH Q7 guideline on good manufacturing practices for active pharmaceutical ingredients:
- It establishes quality management principles for ensuring APIs meet intended specifications, including defining organizational structures, procedures, processes, and responsibilities.
- Manufacturing operations of APIs and intermediates should be clearly defined and documented. Any deviations must be documented and investigated.
- An independent quality unit is responsible for approving or rejecting APIs, materials, equipment, processes, and review of production records, audits and product quality reviews.
- Personnel involved in manufacturing APIs must be qualified and trained. Hygiene practices and facilities must allow for clean and orderly manufacturing operations.
Quality assurance and validation processes are essential for ensuring safe and effective pharmaceutical products. Key aspects of quality management include adhering to ISO, WHO, and other certification standards. Quality assurance focuses on preventing defects during development, while quality control identifies defects after production. Laboratories must follow strict safety protocols like prohibiting food/drinks, regularly disinfecting surfaces, and properly disposing of contaminated materials. Organizations should implement quality planning, control, assurance, and improvement systems.
Quality assurance in the pharmaceutical industryfatboysec
This document discusses quality assurance in the pharmaceutical industry. It states that research, development, production and distribution must comply with global and local rules to ensure medicines are pure, safe and effective. Pharmaceutical companies must satisfy directives from the FDA and EMA regarding GMP, GLP, GCP and GDP. Ordina provides quality assurance services including validation and documentation of processes, training, audit services, and optimization of quality management systems. Ordina experts are knowledgeable in relevant legislation and methodologies to design validation approaches focused on critical quality attributes.
Mark Fermenick has over 25 years of experience in consumer packaging and food production. He has held roles such as plant manager, facilities manager, superintendent, and technical QA manager. He has extensive experience leading teams and driving process improvements through Lean Six Sigma methods. Fermenick has a strong safety record, with over 900 days without an incident, and experience maintaining compliance with third-party certifications.
This document provides a summary of Bill Clark's contact information, work experience, qualifications, and skills. He has over 30 years of experience as a chemical process technician, having worked at several companies including Elli Lilly, Ineous Chlor Vinyl’s, Pentagon Chemicals, Pilkington Glass, Phoenix Chemicals, and Associated Octel Company Limited. His responsibilities have included operating and monitoring plant operations, batch and continuous processing, laboratory analysis, and maintenance duties. He has qualifications in process plant operations and safety training.
This document is a resume for Austin Rine that outlines his objective, education, work experience, and skills. Rine is seeking a position in a company that produces chemicals for the food and agriculture industries. He is expected to graduate in May 2016 with a B.S. in Chemistry from Ohio Dominican University where he has taken relevant coursework and completed projects involving synthesis, analysis, and the Haber process. Rine has experience working in city grounds and maintenance, automotive assembly, and as a cashier at Dairy Queen.
Brandon Creagan seeks a position utilizing his Master's in City and Regional Planning. He has experience completing comprehensive and transportation plans through Ohio State, teaching English in China, and various internships including with the Ohio Governor's office. Creagan has extensive leadership experience with fraternities and student government and is LEED Green Associate certified.
This resume summarizes Jennifer Rose's qualifications for an on-air radio host position. She has experience hosting various radio formats and using studio equipment like ENCO DAD and Adobe Audition. Rose graduated with a diploma in radio/video from Specs Howard School of Media Arts in 2015. She has worked in communications at her high school and as a cashier at Meijer. Her skills include Microsoft Office, Apple software, and social media marketing.
Megan Stritch is seeking a position at Kent State University that allows her to expand her experience in marketing and serving diverse populations. She has work experience in customer service roles including as a cashier, hostess, and administrative assistant. Stritch has also volunteered with organizations assisting those with disabilities. She is currently a senior at Kent State University pursuing a Bachelor's degree in Marketing with a minor in Economics and maintains a 3.2 GPA.
Jonathan K. Mentzer has over 25 years of experience in quality assurance and quality control roles. He has a proven track record of reducing customer complaints and internal quality issues through root cause analysis. His experience includes setting up quality systems, conducting audits, developing testing protocols, and ensuring regulatory compliance. Currently he works as a Quality Assurance Coordinator at Frutarom USA overseeing quality for multiple divisions.
Dr. Alok Kumar Sharma has over 23 years of experience in manufacturing operations and quality assurance in the pharmaceutical bulk drugs industry. He holds a PhD in Organic Chemistry and has worked in leadership roles at several companies, currently serving as Vice President at Kores India Ltd. He has expertise in production planning, quality management, process optimization, and commissioning new plants and products.
Experienced, results-oriented professional with broad experience in pharmaceutical quality processes and problem solving. Expertise in reviewing complaints, SOPs, Batch Records, and other documentation for accuracy and completeness. Skilled in preparing for internal or external audits and correcting deficiencies. Demonstrated ability to bring new facilities into FDA compliance. Proficient in SAP and Trackwise. Areas of expertise:
PQMS | Batch Record Review | Controlled Substances | Document Control
FDA Regulations | Metrics Reporting | GMP / GLP, OSHA
Albert Brantley Jr. has over 30 years of experience in quality assurance and production roles in the pharmaceutical and chemical industries. His experience includes writing validation protocols and standard operating procedures, performing audits, developing quality systems, and managing production. He currently works as a Quality Engineer for Paxico LLC where he leads validation and compliance activities.
The document discusses the role of quality assurance (QA) in the pharmaceutical industry. QA acts as key personnel to ensure customer safety, product quality, and efficacy. QA is involved throughout the product life cycle, from design and development by authorizing documents, evaluating and auditing vendors, to manufacturing through environmental monitoring, calibration, and validation. In post-production, QA oversees stability testing, sample retention, product complaints, and recalls. QA also ensures compliance through activities like change control, deviation handling, audits, and documentation. The overall goals are to build quality into products and make quality the responsibility of all involved in manufacturing.
M. Srinivasan is an experienced Operations Manager with over 18 years of experience in pharmaceutical manufacturing. He has a strong background in production planning and quality assurance. Srinivasan is looking for new opportunities to utilize his skills in operations management, process improvement, quality audits, and machinery maintenance. He has worked for several major pharmaceutical companies and has experience managing facilities, projects, and over 400 employees.
Pilot Plant Scale Up Techniques Used in Pharmaceutical Manufacturing, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgaum/Belagavi
This document provides information on standard operating procedures (SOPs) for manufacturing equipment used in liquid, solid, and semi-solid dosage forms. It discusses what an SOP is, the objectives and benefits of SOPs, types of SOPs, SOP writing style, important points to consider when writing SOPs, and common equipment used to prepare liquid and semi-solid formulations. The document emphasizes that SOPs are essential for ensuring consistent, compliant production operations and for training personnel. They help maintain quality control and assure regulatory compliance.
Quality Assurance Services, Inc. provides quality assurance services including receiving inspection, containment, sorting, inspection, rework, repair, and warehousing for customers. Its mission is to be a successful supplier committed to continuous improvement, customer satisfaction, employee development, long-term partnerships, growth and profitability. It aims to be the industry leader in quality services through strategic partnerships. The company orients its processes around customer requirements and satisfaction through effective inspection, containment of non-conforming products, and meeting production schedules.
The document discusses quality control in manufacturing. It explains that quality control aims to maintain standards and provide feedback to improve future production by minimizing defects. Quality inspection checks for defects but does not provide this feedback. Quality assurance focuses on systems and documentation to avoid issues before production begins. For highest quality, companies should collectively apply quality inspection, quality control, and quality assurance. The document also defines quality costs and categorizes them as prevention, appraisal, internal failure, and external failure costs.
This document discusses pilot plant scale up in the pharmaceutical industry. It defines a pilot plant as transforming a lab scale formula into a viable product through developing a reliable manufacturing process. Conducting pilot plant studies is important as effects of large scale production cannot be predicted from lab data alone. A pilot plant allows investigating products and processes on an intermediate scale before full production. It permits examining formulas' ability to withstand scale changes and modifying equipment, materials, and production rates. The document outlines pilot plant design, operations including validation, training, engineering support, maintenance, quality assurance, and quality control. The significance of a pilot plant is to refine formulas and determine equipment and materials that can consistently meet specifications for reliable manufacturing.
This document discusses personnel validation in the pharmaceutical industry. It covers the need for personnel validation to ensure qualified employees are appropriately trained. Key areas discussed include personnel responsibilities, training requirements and methods, gowning procedures, standard operating procedures, and regulatory guidelines around personnel qualification from organizations like WHO and FDA. The goal of personnel validation is to demonstrate personnel are qualified and aware of their responsibilities to ensure product quality.
Gmp (q7 ich guide) & Stem cells-based therapy product manufacturingM. Agung Sumantri
This document provides a summary of key points from the ICH Q7 guideline on good manufacturing practices for active pharmaceutical ingredients:
- It establishes quality management principles for ensuring APIs meet intended specifications, including defining organizational structures, procedures, processes, and responsibilities.
- Manufacturing operations of APIs and intermediates should be clearly defined and documented. Any deviations must be documented and investigated.
- An independent quality unit is responsible for approving or rejecting APIs, materials, equipment, processes, and review of production records, audits and product quality reviews.
- Personnel involved in manufacturing APIs must be qualified and trained. Hygiene practices and facilities must allow for clean and orderly manufacturing operations.
Quality assurance and validation processes are essential for ensuring safe and effective pharmaceutical products. Key aspects of quality management include adhering to ISO, WHO, and other certification standards. Quality assurance focuses on preventing defects during development, while quality control identifies defects after production. Laboratories must follow strict safety protocols like prohibiting food/drinks, regularly disinfecting surfaces, and properly disposing of contaminated materials. Organizations should implement quality planning, control, assurance, and improvement systems.
Quality assurance in the pharmaceutical industryfatboysec
This document discusses quality assurance in the pharmaceutical industry. It states that research, development, production and distribution must comply with global and local rules to ensure medicines are pure, safe and effective. Pharmaceutical companies must satisfy directives from the FDA and EMA regarding GMP, GLP, GCP and GDP. Ordina provides quality assurance services including validation and documentation of processes, training, audit services, and optimization of quality management systems. Ordina experts are knowledgeable in relevant legislation and methodologies to design validation approaches focused on critical quality attributes.
Mark Fermenick has over 25 years of experience in consumer packaging and food production. He has held roles such as plant manager, facilities manager, superintendent, and technical QA manager. He has extensive experience leading teams and driving process improvements through Lean Six Sigma methods. Fermenick has a strong safety record, with over 900 days without an incident, and experience maintaining compliance with third-party certifications.
This document provides a summary of Bill Clark's contact information, work experience, qualifications, and skills. He has over 30 years of experience as a chemical process technician, having worked at several companies including Elli Lilly, Ineous Chlor Vinyl’s, Pentagon Chemicals, Pilkington Glass, Phoenix Chemicals, and Associated Octel Company Limited. His responsibilities have included operating and monitoring plant operations, batch and continuous processing, laboratory analysis, and maintenance duties. He has qualifications in process plant operations and safety training.
This document is a resume for Austin Rine that outlines his objective, education, work experience, and skills. Rine is seeking a position in a company that produces chemicals for the food and agriculture industries. He is expected to graduate in May 2016 with a B.S. in Chemistry from Ohio Dominican University where he has taken relevant coursework and completed projects involving synthesis, analysis, and the Haber process. Rine has experience working in city grounds and maintenance, automotive assembly, and as a cashier at Dairy Queen.
Brandon Creagan seeks a position utilizing his Master's in City and Regional Planning. He has experience completing comprehensive and transportation plans through Ohio State, teaching English in China, and various internships including with the Ohio Governor's office. Creagan has extensive leadership experience with fraternities and student government and is LEED Green Associate certified.
This resume summarizes Jennifer Rose's qualifications for an on-air radio host position. She has experience hosting various radio formats and using studio equipment like ENCO DAD and Adobe Audition. Rose graduated with a diploma in radio/video from Specs Howard School of Media Arts in 2015. She has worked in communications at her high school and as a cashier at Meijer. Her skills include Microsoft Office, Apple software, and social media marketing.
Megan Stritch is seeking a position at Kent State University that allows her to expand her experience in marketing and serving diverse populations. She has work experience in customer service roles including as a cashier, hostess, and administrative assistant. Stritch has also volunteered with organizations assisting those with disabilities. She is currently a senior at Kent State University pursuing a Bachelor's degree in Marketing with a minor in Economics and maintains a 3.2 GPA.
Ryan McClain is a talented operations coordinator with experience in strategic planning, process improvement, systems implementation, and marketing. He spearheaded several new programs at Heartland of Marysville, including a cardiac rehab program and cooking classes for diabetics. McClain also implemented a "Walk with a Doc" program. He has experience assessing patients, discharge planning, managing budgets, and optimizing the customer experience through various programs and process improvements.
Joseph DiMattia is seeking a challenging role that utilizes his organizational skills, administrative expertise, and leadership experience. He has over 15 years of experience in office administration for an addiction treatment clinic where he directs administrative work and assists program directors. Additionally, he has over 10 years of retail management experience as a shift manager for a bakery and assistant operations manager for a clothing store where he oversaw daily operations and trained and managed staff. He is proficient in Microsoft Office and communication skills.
Adam Wilkins is seeking a full-time production manufacturing position at Honda of America in Marysville. He has experience working on assembly lines from Heritage Cooperative and Ohio State University, including with small engines, agricultural machinery, and construction equipment. Wilkins attended Ohio State University, Clark State Community College, and Columbus State Community College, earning over 100 credit hours. His work history includes positions at Bob Evans, Heritage Cooperative, The Buckeye Room, and Pop's Pizza, where he gained experience in inventory, ordering, customer service, and opening/closing duties.
Jessie Lee Hall is seeking a challenging position in transportation using her commercial driver's license. She has excellent driving skills as well as skills operating equipment like a Bobcat skid loader and forklift. Her education includes a building maintenance program and she has various work experiences including as a forklift operator, order selector, and receiver/stocker at distribution centers.
Siearra Papuga is a student at Lesley University studying Business Management with a concentration in Arts Management. She has worked in several roles in the arts and entertainment industry including at House of Blues and Cuchi Cuchi restaurant. Her experience includes event set up, customer service, administrative support, and website design. She is energetic, organized and has strong communication skills. Upon graduating in 2016, she hopes to find a job that utilizes her skills in project management, customer service, and arts administration.
Olrick Lucien is an experienced executive director and general manager with over 15 years of experience in operations management, client relations, and financial planning for health clubs, restaurants, and hotels in the Boston area. He has a proven track record of exceeding sales goals, improving customer satisfaction, managing multi-million dollar budgets, and developing high-performing teams. Currently he is the General Manager at United Service Companies, where he provides oversight for local small business accounts.
Matt Taylor has over 15 years of legal experience in both public defense and private practice. He currently manages the Oregon office of Patenaude & Felix, A.P.C., overseeing litigation and client relations. Previously he worked as a public defender in Oregon for 6 years. Taylor received his J.D. from Lewis & Clark Law School and has held legal internships and clerkships focused on environmental and social justice issues. He also has experience in outdoor education and wilderness instruction.
Kathleen Nichols has over 18 years of experience in administrative management, organization training, and youth programs. She currently serves as the Director of Youth Programs for the Ohio Attorney General's Office, where she manages a budget of $320,000 and provides cyber safety training to over 500,000 students and adults annually. Previous roles include Program Director for the Union County Prosecutor's Office, where she expanded victim assistance services by 300%, and Medical Social Worker at Memorial Hospital, where she developed a prenatal loss program. She is a recognized expert in topics like cyber bullying, sexting, and school safety, and has presented at over 60 national, state, and local conferences.
Molly Fenby is a dedicated leader experienced in sales, customer service, and operations management. She has over 15 years of experience leading teams, driving revenue growth, and ensuring optimal performance. Her experience includes roles as Director of Operations for Aquatic Adventures Ohio, where she facilitated significant membership growth and profitability increases, and Aquatics Director roles with the Union County YMCA and Sonoma County Family YMCA, where she expanded programming and increased revenue. She holds a Bachelor's degree in Recreation from Bowling Green State University.
Richard Savage is seeking an IT position that utilizes his skills and experience. He has over 15 years of experience in various IT roles including desktop support, field service technician, and plant technical analyst. He has worked with companies such as Giant Eagle, Conexess Group, Astyra Corporation, Pomeroy IT, Care Fusion, and Cardinal Health. Richard has extensive experience with Windows 7, deployments, hardware and software troubleshooting, networking, and customer service. He has several technical certifications and military experience in the United States Marine Corps and Army National Guard.
This document is a resume for Mayra I. Casiano summarizing her experience in the medical device and pharmaceutical industries. She has over 20 years of experience in manufacturing, process/packaging, technical services, and validation. Some of her responsibilities have included leading manufacturing operations, implementing technology transfers, ensuring regulatory compliance, and authoring standard operating procedures. She is proficient in validation protocols for facilities, equipment, and processes.
Jesús Gerardo López Solis is seeking to continue growing his skills and applying his knowledge and experience to achieve company goals at a well-established company. He has over 15 years of experience in manufacturing roles of increasing responsibility at Johnson & Johnson, including his current role as Line Coordinator where he supports four manufacturing lines and leads manufacturing activities. He holds a BS in Industrial and Systems Engineering from Universidad TecMilenio and is a certified Lean Six Sigma Yellow Belt.
I am seeking to obtain a position with a progressive, large international company or organization offering responsibility, advancement& individual growth.
•To find a career opportunity that would utilized abroad range of my experience
•To work in a dynamic & corporate environment, which will enable me to apply my expertise and problem solving skills, gained through advanced tertiary qualifications, work experience & international accreditations, to the best benefit of organization thereby achieving symbiotic growth
Zack Hayer has 15 years of experience in high-tech manufacturing in Silicon Valley. He has expertise in process engineering, manufacturing engineering, facility maintenance, and supervising technicians. His skills include sputter coating, vacuum systems, ISO 9001 clean rooms, and process control. He aims to optimize processes, improve efficiency, and solve manufacturing problems.
PILOT PLANT SCALE- UP TECHNIQUE
Plant, Pilot Plant, Scale-up, Objective, Significance, Steps in scale up, General considerations, Master Manufacturing Procedures, GMP consideration.
I am seeking to obtain a position with a progressive, large international company or organization offering responsibility, advancement& individual growth.
•To find a career opportunity that would utilized abroad range of my experience
•To work in a dynamic & corporate environment, which will enable me to apply my expertise and problem solving skills, gained through advanced tertiary qualifications, work experience & international accreditations, to the best benefit of organization thereby achieving symbiotic growth.
Mr. Graham P. Alvey has over 15 years of experience in quality engineering, quality assurance, and validation roles in the pharmaceutical and medical device industries. He has a strong technical background and skills in quality systems, auditing, data analysis, and process improvement. His most recent role is as Product Quality Engineer at PerkinElmer Ltd. where he is responsible for quality of products and developing quality processes and procedures.
Charles Henderson has over 10 years of experience in manufacturing technical support roles for pharmaceutical companies. He has extensive expertise in areas such as manufacturing operations, quality assurance, compliance, process improvement, and project management. Currently he works as a Manufacturing Technical Support Specialist at Roche Carolina, where he provides technical support for API manufacturing and leads projects involving qualification, technology transfer, and compliance.
Brenda Hugh is an experienced manufacturing and quality manager specializing in technology transfer, lean manufacturing, and quality systems. Over her 20+ year career, she has held leadership roles at Charles Stark Draper Laboratories and SRU Biosystems, focusing on product quality and customer satisfaction. In this presentation, she discusses her career highlights, leadership style, manufacturing experience, and qualifications for a manufacturing manager role.
The summary provides information on Kristine Kowalski's background and experience in quality assurance, validation, and regulatory affairs. She has over 13 years of experience in these fields, including serving as the Validation Manager at Cody Laboratories for over 4 years. She has extensive experience leading validation projects, writing documentation, ensuring compliance, and mentoring others. Her skills include validation, cleaning validation, computer system validation, and regulatory submissions.
Industrial Pharmacy Unit IV -WPS Office.pptxSudipta Roy
This document provides an overview of quality management systems and standards. It discusses Total Quality Management (TQM), characteristics of TQM including management commitment and continuous improvement. It also covers ISO 9000 quality management system standards, describing ISO 9001 and benefits such as satisfying customers and regulatory requirements. Finally, it introduces ISO 14000 environmental management standards, describing ISO 14001 and its role in helping organizations minimize environmental impacts and comply with regulations.
Daryl Bryant has over 20 years of experience in pharmaceutical and chemical processing, including tablet compression operations, batch processing, chemical operations, process controls, and quality control. He is currently a Chemical Operator at Integra LifeSciences, where he oversees collagen-based skin product manufacturing and ensures compliance with standards and regulations. Previously, he worked at Merck for over 25 years in various roles such as Senior Tablet Compression Operator and Warehouse Monitor, helping to develop major drugs and drive improvements in efficiency.
1. A pilot plant allows for transforming a lab scale formula into a viable product by developing reliable manufacturing procedures at an intermediate scale. This helps identify any issues before committing to full-scale production.
2. Key objectives of a pilot plant include evaluating results from laboratory studies, producing small quantities of product for testing, and determining parameters for full-scale production.
3. Important considerations for pilot plant development include the type and size of equipment needed, proper location, staffing requirements, and ensuring compliance with Good Manufacturing Practices.
Jess Mc Govern has 3 years of experience in a GMP laboratory, including method development, validation, equipment qualification, data review, and training. They hold a BSc in Industrial Biochemistry and are proficient in analytical techniques like HPLC, GC, and UV/Vis. In their current role at Eurofins Lancaster Laboratories, they perform pharmaceutical analysis, write reports, and assist in management responsibilities. They are organized, a strong communicator, and enjoy artistic pursuits and traditional Irish music in their free time.
Gwendolyn Beagle has over 37 years of experience in chemical manufacturing, including roles in quality assurance, quality control, and production operations. She is currently the Quality Assurance/Quality Control Supervisor at Great Lakes Chemical, where she manages the quality control lab and ensures compliance with ISO and regulatory standards. Throughout her career, she has facilitated numerous continuous improvement initiatives focusing on safety, quality, and cost reductions.
Angel Mario Jusino Berrios is an experienced registered pharmacist with extensive experience in the pharmaceutical industry, managing consent decrees and ensuring regulatory compliance. He has held senior roles providing quality consulting services, including implementation of validation guidelines, quality system assessments, and preparation of regulatory reports. Berrios has expertise in areas such as quality system implementation, process validation, remediation programs, auditing, and technical strategies.
Kevin P. Koski has over 21 years of experience in project leadership, process engineering, product development, manufacturing, quality control, and project management in the pharmaceutical and medical device industries. He currently works as a Senior Manager of Manufacturing Technical Support at Roche Carolina Inc., where he leads technical support projects and quality initiatives. Previously he held roles in process development, engineering, and operations at Talecris Biotherapeutics, Bayer Healthcare, and Grifols Therapeutics. He has extensive expertise in all stages of product development and manufacturing processes.
Bill Stockton has over 13 years of experience working in cGMP manufacturing facilities. He has skills in processing, manufacturing, laboratory equipment, chemical and biological safety procedures, and computer programs like Word, Excel and Outlook. His work history includes positions as a process technician at AT&T, lab technician at Merck/Spectraforce, and formulator at Catalent. He also has experience working at various pharmaceutical companies, including Baxter Healthcare, Dentsply, and CSL Behring in roles following cGMP guidelines.
- Celeste Fralick is a Principal Engineer and Chief Data Scientist at Intel with over 25 years of experience. She leads an Analytics Center of Excellence and has developed complex algorithms and predictive models that have generated over $2B in revenue.
- Her experience spans several roles in engineering, quality assurance, operations, and data science at Intel, Medtronic, National Semiconductor, Texas Instruments, and Fairchild Semiconductor.
- She holds a PhD in Bioengineering from Arizona State University and has authored patents and publications in analytics, medical devices, reliability, and quality systems.
Tracey Richardson is a highly motivated Quality Assurance Professional with over 20 years of experience leading quality programs and initiatives. She has extensive experience developing quality programs and procedures for medical devices at Labotix Automation and leading quality and process improvement projects at PepsiCo Canada, generating significant cost savings. Her background includes developing quality manuals, SOPs, functional and technical specifications, and validation plans and protocols. She has strong skills in project management, training, statistical analysis, and computer systems.
1. Alan Cormier Page One
206 Exchange Street
Leominster, Ma 01453
(978) 537-5071
(978) 265-5189
Alancormier23@yahoo.com
Summary
Leadership with 10 years’ experience in Medical & Biotechnology in production manufacturing and laboratory facilities,
planning and development. Introduced new methods into the manufacturing process in class 100 clean rooms supporting
clinical and commercial operations. Knowledge in the state of the art manufacturing technologies and processes GMP,
cGMP, GLP, ISO 9001. Noted for being poised / confident, efficient, responsible and organized. Strong attention to detail,
proven ability to problem solve and troubleshoot; Excellent interpersonal skills at departmental levels.
Technical Skills:
• Production Process and standards.
• Quality and Performance Improvement.
• Higher Standards of Procedure and Products Over ten years of Biotechnology experience in a Manufacturing
environment Involved with FDA guidelines.
• Successfully supervised and trained a network of Twenty Technicians.
• Strong skills in communication, customer service, organization and leadership.
• WPI Project Management.
• Process automation Purification systems upstream down stream purification.
• Proficient in Process Development and projects, cross functional tasks.
• Trouble shoot maintain equipment, various hardware settings.
• Validation and development of systems for clinical and commercial operation.
• Experienced in Purification systems.
• Highly organized: Strong attention to detail: able to effectively interface with people.
Formulation Technician II 2013 / 2014
Bio-Techne Devens, Ma
Responsibility RNA Medical, a trademark of Bio-Techne providing quality controls materials and related products for blood
gas, POC Glucose, critical care, and diabetes care platform for calibration verifications of QC products diagnostics and
services to hospitals and healthcare facilities worldwide.
• Performed preparing production equipment for filling operation.
• Responsibility preparing formulations according to written procedures.
• Optimized work efficiency, structured discipline and met on time delivery requirement.
• Performed daily QC on laboratory instruments, (ABL) Blood Gas Radiometer, (YSI) (NOVA) conductivity meter.
• Preformed daily calibration checks on balances scales.
• Managed a variety of chemical and Biochemical tests, conducted testing and recording data on using various
laboratory equipment including working with R&D to resolve issues with formulations prior to manufacturing.
• Used the ECO process to remedy problems with formulations and documentation.
• Ability to perform critical thinking excellent attention to detail solution focused and ability to multi task, exceptional time
management skills and to work well under pressure to drive effective critical timelines.
Manufacturing Technician II 2013 / 2013 Contract
Genzyme Corp. Framingham, Ma
Responsibility in the Bio surgery manufacturing operations production of Seprafilm Adhesion barrier class III medical
device. A sterile bio absorbable translucent membrane applied during surgery helping prevent adhesion, or internal scars,
separates organs between adjoining tissues after open surgery.
• Conducted and provided support in all manufacturing activities in areas involved processing equipment inside
environmental controlled areas.
2. • Manufacturing related equipment involving re-suspension tank, casting machine, drying chamber, floor or and table
top scale, automatic sheet washer.
Alan Cormier alancormier23@yahoo.com Page Two
• Provided support for production in multi hand machine operation duties associated with material preparation and
testing casting and loading for manufacturing batch lots ensuring product quality.
• Strong working knowledge of CGMP, GMP, SOPs, prepare, assemble and operate manufacturing equipment, batch
record procedure, track wise, respond to trouble shooting.
• Process automation systems, change various hardware settings. Perform raw material handling; sanitization and
sterilization clean in place (CIP) ( SIP ) achieve target production goals to customer request.
Senior Manufacturing Technician 2009 / 2013
Allergan Medical Inc. Medford, Ma
Successfully lead, supervised and trained a network of ten technicians giving support in a master priority for surgical Seri
Scaffold a knitted multi filament a bioengineered platform technology in medical surgical prosthetic device.
• Involvement in Tissue Regeneration development of human tissue repair and reconstruction, revision augmentation,
abdominal wall repair.
• Proprietary methods on advanced operation systems/ repair, (ACL) and breast reconstruction, revision augmentation,
abdominal wall repair.
• Proprietary methods on advanced operation systems/ conducted and provided hands on in all clinical manufacturing
activities performing set up operation/ equipment associated providing in operation procedures. “Automated system,”
Programmable Logic Controller ( PLC ) De-ionized water systems, “Extraction” to remove material from twisted silk
yarn, “Twist-tech” used to form filaments of raw silk into twisted plies, “Finishing” machine used to rinse, coat and dry
knitted product, “Knitted Comez” takes individual yarns loaded on a creel and combines them into mesh fabric.
• Responsibility in managing and performing cycle counts on all CGMP materials included purchase requisition on data
management systems to meet production needs and providing hands on support to process development and
engineering initiatives.
• Responsibility in conducting group morning meeting with the following people and departments. Quality Control,
Micro, Engineering, Manufacturing, supervisory, Management, and facilities.
• Daily disquisitions are manufacturing weekly schedule involved with strategic production planning achieving target
production goals to customers request and target lead times,
• Manufacturing issues, Deviations, Capa, equipment issues, incident reports. EHS, Identify unsafe work practices and
conditions and develop appropriate remedies.
• Ability to perform complex test operation and operate and maintain test equipment, preventive maintenances, as
required per an established schedule on manufacturing related equipment involved communicating and
troubleshooting problem areas with engineering management.
• Wrote standard operation procedures (SOP) and batch record reviewing deviation reports. Support initiatives towards
implementing a manufacturing structure/ system.
• Ability to perform critical thinking excellent attention to detail solution focused and ability to multi task, exceptional time
management skills and to work well under pressure to drive effective critical timelines.
Environmental Health & Safety 2009 / 2009 Contract
Shire, Human Genetic Therapies Inc. Cambridge, Ma
Enhance site safety culture and reduce injuries by improving safety communication across the site, identify barriers and
developing and implementing solutions. Identify unsafe work practices and conditions and develop appropriate remedies.
• Wrote and reviewed accident investigations/ incident reports, including causes and trends.
• Provided support and served as a resource in the development, implementation, and maintenance of comprehensive
safety & health programs.
• Performed and document site specific internal and inspections to ensure compliance with corporate policies and
procedures.
• Inventory records keeping, waste management and industrial hygiene assist with chemical and noise monitoring,
participated on safety committees, investigate complaints.
• Administrator for new hires and enrolling employees for on line training programs, including involvement with
performing safety related training for new hires and employees.
3. Alan Cormier alancormier23@yahoo.com Page Three
Ma Precommerical Manufacturing Associate II 2006 / 2008
Alkermes Inc: Cambridge, Ma
Conducted and provided support in all clinical manufacturing activities areas that produce a pipeline of extended release
injectable, pulmonary and oral product.
• Introduced productivity improvement and performance that improved production output, production quality and
customer satisfaction.
• Assisted in development of a 3500 SQ FT class 100 state of the art clean room for the production of batch filling
injectable and pulmonary oral products.
• Held position of Supervisor, Group leader and Trainer in class 100 clean room of production batch filling ensuring
product quality and sterility.
• Coordinated of validations and developed of systems for clinical and commercial operations...
• Optimized work efficiency, structured discipline and met on time delivery requirement, enhanced customer
satisfaction, and reduced quality complaints by 30%.
• Involved with strategic production planning achieving target production goals to customers request by 98%.
• Wrote standard operation procedures (SOPs) and Batch Record Reviewing Deviation reports.
• Strong working knowledge of cGMP, GMP, SOP and keen problem solving and investigation skills. Experience in
Trackwise, data management system.
Manufacturing Associate Scientist 2005 / 2006
Zeptometrix Corporation: Franklin, Ma
Held Responsible for the manufacturing of serology control panels and screening kits used for diagnostic testing by
researchers worldwide in the field of infectious diseases, cancer oxidative stress and other biomedical studies.
• Improvement and performance with defibration plasma filtrations HIV plasma titrations, clinical EDTA titrations, sterility
testing, and serial dilutions material validations.
• Optimized work efficiency, structured new filter skids preparations in the purifications systems.
• Assisted in special assignments for the CDC and World Wide Who organization
Associate Scientist 2003 / 2004 Contract
Bristol-Myers & Squibb: Franklin, Ma
Identified the purity of nuclear radiopharmaceuticals in the medical industry worldwide.
• Involved with FDA guidelines in radiation handling protocols development and implementation to reduce risk handling
• Performed identification tests including Radionuclide, Radiochemical purity, Alpha analysis, perform wet chemistry
testing, and data base management.
Bioscience Technician 2002 / 2003
Biopure Corporation: Cambridge, Ma
Manufacturing process involved of involved in the manufacturing ultra-purified hemoglobin used by the medical and
veterinary fields worldwide.
• Resolved sample failure, through mechanical and chemical testing, and inspection.
• Involved in the improvement of the purification process; sanitization and sterilization, including filter skids, changing
various hardware settings in the purification system, and protocols
• Process automation systems upstream down stream purification
• Manage the performance calculations necessary in determining material consumption rates on flow filtration devices
Education:
• Business Management course, Middlesex Community
• CollegeCorporate Sponsored Seminars - Hazmat Training
• Risk Management ~ Track wise Software Training.
• Project Management (Presented by WPI) ~ Data Management System (Genie HMI)