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
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
Dynamic and extroverted individual with 2 years of hands-on experience in developing and presenting protocols. Profound knowhow of handling filling and collating duties to manage appropriate documentation
Dynamic and extroverted individual with 2 years of hands-on experience in developing and presenting protocols. Profound knowhow of handling filling and collating duties to manage appropriate documentation
• Competent professional with 10+ years of experience in executing
In-process quality assurance by monitoring complete pharma
manufacturing process in order to comply with the specifications
• Over all responsible for IPQA Activities (both manufacturing and
packing area of solid orals, Nasal spray and Liquid dosage forms)
• Ensure the compliance of quality events like deviation
management, temporary change control, permanent change control, CAPA, Market complaints.etc.
• Active participation in root cause investigation and proposal of CAPA for deviation, market complaint and batch failure.
• Effectiveness check of implemented CAPA in shop floor.
• Calibration Management –ensure calibration of all IPQA instruments as per schedule.
• Skilled in preparation and review of Annual Product Quality Review (APQRs)
• Review of SOPs/work instructions-Gap identification and compliance of the same.
• Conducting in-house cGMP audits to ensure compliance and sound functioning of the process.
• Provide training regarding any changes to existing system and introduction of any new system.
• Knowledge on OOS, OOT, Site Master File.
• Hands-on experience in preparation of Process validations, cleaning validation, hold time study protocols and BMR and BPR preparation.
• Making Sure that products are manufactured according to legal and Customer requirements.
• Diligently Verifies document Completion and Compliance.
1. Robert Zeider
1556 Calle La Cumbre, Camarillo, CA 93010 · 805.204.7166 · robert.zeider940@gmail.com · linkedin.com/in/robertzeider
WORK EXPERIENCE
Shire Plc, Thousand Oaks, CA Jun. 2014 – Present
Quality Analyst I – Formulation, Filling and Finishing
Experienced at making real-time Quality/GMP decisions during manufacturing operations.
Experienced at reviewing QA Documentation and revising SOPs, Runsheets, and Forms.
Qualified in Packaging Batch Record Review and the Inspection of Filled Unlabeled Vials.
Qualified trainer in all quality roles overseeing aseptic filling, capping and packaging operations.
QA subject matter expert streamlined aseptic filling operations as QA subject matter expert.
Received an “Exceeds Expectations” review for strong work ethics and diligence to quality.
Knowledge of good aseptic practices including: cGMP, ISO Class 5-9 gowning, and Federal
Regulations 21 CFR – parts 210 & 211.
Managed issuance, segregation and destruction of QA controlled product, material and labels.
Experienced at navigating in J.D. Edwards EnterpriseOne, SQL LIMS, PLMS.
R.L. Zeider Incorporated, Camarillo, CA Jan. 2011 – Present
Operations Specialist /CNC Mill and Wire EDM Operator
Oversaw manufacturing operations of precision medical-grade titanium implants utilizing Computer
Numerical Control Mills (CNCs) and Wire Electric Discharge Machines (EDMs).
Increased production nearly two-fold by developing a streamlined manufacturing schedule that
staggered all automated process to ensure maximum productivity over a 24-hour cycle.
Inspected for and maintained a high degree of accuracy and precision required for medical implants.
Responsible for troubleshooting production issues, deviations, NCRs/CAPAs.
Oversaw customer audits, and implemented revisions to documents, training and/or Preventative
Maintenance scheduling to meet/exceed requirements.
Created SOPs, Runsheets and inspection forms for the manufacturing and segregation of multiple
medical devices with varying material lot identifications at different stages of manufacturing process.
Created training programs for Manufacturing, Inspection and Preventative Maintenance.
Reviewed raw material stores and purchase orders to ensure on hand quantities met demand.
Created system for organization of Invoices, Material Certifications, Material Safety Data Sheets
(MSDS), Quality Assurance/Inspection forms, and equipment Preventative Maintenance forms.
SKILLS
Quality/Manufacturing: cGMP, cGDP, ISO Class 5-9 Gowning, 21 CFR – parts 210 & 211,
Packaging Batch Record Review, FUV Inspection, Document Review/Revision
PC Software: Microsoft Windows and Office Suite (Excel, Word, PowerPoint), JD Edwards
EnterpriseOne, Kaye LabWatch, SQL*LIMS, IBM SPSS Statistical Analysis Software
EDUCATION
Bachelor of Science in Biology, California State University Channel Islands Fall 2013
Minor in Chemistry
o Biology: Cell Biology, Molecular Biology, Genetics, Biostatistics, Animal Physiology
o Chemistry: General Chemistry, Organic Chemistry, Quantitative Chemical Analysis