Cesar Espada is seeking a position as a line lead or quality assurance inspector and has over 5 years of experience in planning, operations, quality control, production, and warehouse work. He has a background in pharmaceutical manufacturing and medical device production. His resume lists experience in roles such as line lead, quality assurance inspector, and cleanroom technician at companies including Sun Pharma, Johnson & Johnson, and Zeus Inc. Espada has skills in areas like batch record review, sampling, inspection, inventory management, and computer programs like SAP and Minitab.

1. CESAR C. ESPADA
North Plainfield, NJ-07060
908-462-4887 cespad30@outlook.com
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LINE LEAD MACHINE OPERATOR, QA INSPECTOR AND
CLEANROOM TECH
Seeking a position as a Line Lead. Good communication skills and also able to work as a part of team.
Background encompasses more than five years of professional experience with skills and qualifications in
the area of planning, inventory control, blood bank, operations, quality control, compliance, production,
and warehouse. I’m also able to work with carrying up to 50 lbs and Packing, picking, printing labels,
copying and faxing documents, inventory store, Bi-lingual (English & Spanish) OSHA Training, SOP
Training, GMP Training, MS Word and data entry. I can also work and fix Computers (Hardware and
software).
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Work Experience
Sun Pharma industries.
Quality Assurance Inspector (March 2016 – June 2016)
 Verifies and line clearance for dispensing, manufacturing and packaging activity. Perform batch
record review, random sampling and in-process testing, and final AQL visual inspection of
finished bulk product.
 Performs manufacturing and packaging record review, random sampling and in-process testing,
and final AQL inspection of packaged finished product
 Verify dispensing activity and review of Pharmacy stage BMR.
 Verify the cleanliness of the rooms and equipment, and performs line clearance activity in
manufacturing and packaging areas.
 Verify Manufacturing activity and review of Manufacturing BMR between stages.
 Online BMR review and random sampling and performs in process tests.
 AQL visual inspection of finished bulk product and collect samples for QA testing.
 Ensure manufacturing area, log books, utility systems are compliant per GMP and in house
procedures.
 In process checks & Monitoring of Manufacturing & Packaging activity
 Review Packaging Batch record
 Collect Retain samples and Stability sample.
 Maintain and perform annual visual inspection of retain samples
 Perform activities related to receipt, storage, inspection and issuance of labeling components
 Inspect and sample raw materials & Bulk Product
 Additional duties as assigned by the Manager

2. Johnson & Johnson companies.
OCD, Ortho Clinical Diagnostics, Johnson & Johnson. (June 2010 – February 2016)
 Perform Line Lead – Technician II
 Experience with Work Standard Construction.
 Red Line, review, edit and renew Process Documents.
 Communicating any issues/problems to supervisor, team leader, technician or engineer and
interact with other functional groups to resolve these issues/problems.
 Performing Daily/hourly report of production specifying all the downtime.
 Assure that components and finished products meet standards of approval with respect to product
identity, physical attributes and packaging.
 Generated and Implemented process improvements on the lines.
 Maintain component and inventory levels for production batches.
 Revised all lines BTR to make sure they are in alignment with the process.
 Make optimum use of the resources in the manufacturing floor to meet short and long term goals
 Support root cause investigation and implement solution
 Communicate and work with supporting groups planning, QC, QE and PQ and management to
drive progress
 Translate complicated ideas and instructions to team
 Schedule and support multiple validation that improved yield and production goals
 Coordinated bulk withdraws
 Sure employees follow company guiding principles and regulation.
 Perform filling, sealing, labeling packaging and inspection of the Strictly follow all regulations
and requirements including cGMPs, OSHA, SOPs and Universal and Product License
requirements.
 Responsible for Inspection Certification of all employees and other in the plant that support
Developed new talent within the team.
 Precise, accurate and completion of the batch records and Documentations related to filling,
labeling, packaging and inspection.
 Certified Quality Assurance Inspector
 Monitor environmental conditions within the filling room (temperature, humidity, RODACs,
particles counts). Monitor environmental conditions and storage of products.
 Use current documentation system to review and print specifications and procedures. Use of PC
for label generation and date tracking and evaluation.
 Use of inventory management systems (AMAPS) for inquiry, receipts and cycle counts.
 Embrace Process Excellence and Lean Manufacturing Principles.
 Use of inventory management systems (SPIDER, SAP) for inquiry and receipts and cycle counts.
 Completing batch records and reviewing component reconciliations.
 Perform QA inspection for all the products.
 Track and trend process to implement process improvements
 Able to drive quality business results
 Work hard to goals and objectives based on business plan
 Ensure accurate inventory levels at all times
 Find opportunities to reduce waste and increase capacity (LIFR)
 Reinforce accountability
 Ensure validations are executed correctly
 Ensure employees are following safety and environmental guide lines at all times
 Coordinate with the quality assurance personnel to ensure production meet acceptable standards
 Participate in audits, as required
 16 Months as a temp with Kelly Services.

3. Zeus Inc.
Medical, Fluid Handling, Electrical, Mechanical Products
 Extensive work with milling machine and making plastic medical tubes.
 Diagnosing, troubleshooting and repairing faulty machinery and equipment.
 Perform QA inspection for all the products.
 experience in a clean room , preparing the material that was to be used. Washed the recipients
that was going to be used and that was being used with alcohol and hot water.
 Training in cleanroom operations and aseptic technique.
 Finally spraying IPA and dry with air and protect with dust cover
 Fill the paperwork than the material is done and stick a label with our initials
Ethylene Inc., Somerset
Mechanical and Petroleum Products
 Experience with setting up machines that worked with ovens
 Experience working with suite for clean room tech.
 Prepared materials in a room where everything was to be sterilized before we made the mixture
that we used
 Aspiration systems,weighing scales,orbital shakers,and computers to enter data and
generate reports. Maintain inventory of processing supplies in the cleanroom.
 After the products came out of the oven we had to clean it superficially
 Mixed products carefully and used a scale to weigh it carefully.
 Perform QA inspection for all the products.
 Lathe machine experience 1 year.
Hospital of Solidarity, Lima Peru
Supervisor
 Supervisor of the computer are
 Experience with computer hardware and software.
 Prepare and review all the hospital documentation.
 Prepare statistics about production and frequently diseases weekly and monthly.
 Maintenance of all computer.
Education
National University of Engineering, Lima, Peru
Associate in Computer Science
ESL Level 6- Graduate 2010 Union County College
Training / Certification
Professionalism ♦ Creative Leadership ♦ Train the Trainer ♦ Conduct Performance Appraisals ♦ Conduct
Performance Improvement Plans ♦ Succession Planning♦ Developing Your Emotional Intelligence
Computer Proficiency
Excel ♦ Word ♦ PowerPoint ♦ SPIDER ♦ SAP ♦ OTIS ♦ Visio ♦ Minitab
Awards
♦ Successful Inspections ♦Customer focus ♦ Achieve Results ♦Act decisively

4. CESAR C. ESPADA
North Plainfield, NJ-07060
908-462-4887 cespad30@outlook.com
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REFERENCES
LOWONE HOOKS
Line Lead
Ortho Clinic Diagnostic
1001 US Highway 202
Raritan, NJ 08869
(908) 462-4290
RAFAEL OLAYA
Group Leader
Ortho Clinic Diagnostic
1001 US Highway 202
Raritan, NJ 08869
(908) 313-8523
MICHAEL NUNEZ
Quality Assurance Inspector
Sun Pharmaceutical Industries
270 Prospect Plains Rd
Cranbury, NJ 08512
(201) 755-5023
AMITKUMAR DAVE
Group Leader
Quality Assurance Inspector
Sun Pharmaceutical Industries
270 Prospect Plains Rd
Cranbury, NJ 08512
(631) 413-5004