Jay Patel
Quality Auditor
Parlin,NJ
Summary
Diligent Quality Assurance Auditor with solid background in auditing processes and compliance evaluation. Successfully identified and resolved quality issues, ensuring adherence to industry standards. Demonstrated analytical skills and attention to detail in conducting thorough reviews and maintaining accurate records.
Overview
3
3
years of professional experience
Work History
Quality Auditor
Merck
Rahway, New Jersey
04.2024 - Current
- Review/Approve GMP Manufacturing Batch Records, Raw Material Confirmation Sheets, Analytical Specifications, Clinical Certificates of Analysis, Retest Documentation, Method Templates, Stability Data, and other Quality Related documents for Regulatory Filings.
- Ensure deviations are classified, investigated and resolved.
- Author / Review / Approve GMP Documentation.
- Author / Review / Approve Standard Operating Procedures.
- Support Audits and Inspections (Health Authority, Internal, Divisional)
- Perform laboratory Walk-Throughs.
Microbiologist
Nutrabio Labs
11.2023 - 04.2024
- Conduct microbial testing on finished products detecting contaminants such as E. coli, Salmonella, Coliform, Yeast, Mold, and Total Viable Count (TVC).
- Perform proper dilutions for bacterial samples to ensure precise test results and interpret colony counts for quantifying contamination levels.
- Develop and maintain validation protocols for environmental controls.
- Perform laboratory analysis on sterilized materials, conduct tests on component samples, identify contamination, and initiate corrective measures.
- Monitor physiological and morphological characteristics to identify microorganisms.
- Investigate issues and prevent GMP problems in samples.
- Maintain accurate records, document microbiology laboratory processes, and prepare final reports.
- Manage purchase orders for laboratory processes and monitor inventory.
- Used ATP testing to monitor environmental cleanliness.
- Responsible for writing and updating the following Standard Operating Procedures (SOPs): Agar Preparation, Microbial Testing, Good Microbiological Lab Practices, Spillage Management, Maintaining Stock of Media, General Safety in the Microbiology Lab, and Disposal of Microbial Waste.
Quality Control Technician
Nutrabio Labs
09.2023 - 11.2023
- Adhere to safety rules, SOPs, and cGMP guidelines.
- Maintain calibration of quality control equipment to ensure accurate testing procedures.
- Conduct chemical and physical testing on samples from Raw Material, Finished Product, In-Process, and Packaged Product phases following standard testing procedures (STP).
- Prepare precise daily records and documents, reporting laboratory results with accuracy.
- Evaluate data reports, promptly identifying and noting any relevant deviations from established standards.
- Prioritize safety and housekeeping by following safety rules, wearing required equipment, and maintaining clean work areas and equipment.
- Communicate quality or compliance concerns promptly and effectively.
- Ensure compliance with federal and state laws, as well as company standards and specifications.
- Utilize analytical techniques for measuring NFTIR, pH, density, color, odor, and appearance.
- Perform analysis of defects and interprets quality control rejection and failure trends.
CAR-T Manufacturing
Bristol Myers Squibb
03.2022 - 09.2022
- Maintained accurate documents, records, and logbooks to track production.
- Practiced safe work habits by adhering to standard operating procedures and guidelines.
- Production of cell culture lots through harvest and cryopreservation.
- Executed viable cell counts to determine concentration.
- Bioreactor sterilization, startup/shutdown, extracting cells, and troubleshooting.
- Expert on Biosafety Cabinet maneuvers and skills.
- Used buffers and reagents within a cell processing system.
- Performed environmental monitoring, aseptic welding, and pipetting.
- Practiced aseptic clean-room techniques, GDP, and GMP.
- ISO 7 Gowning Qualification.
Education
Bachelor of Science - Biology
Rowan University
Glassboro, NJTimeline
Quality Auditor
Merck
04.2024 - Current
Microbiologist
Nutrabio Labs
11.2023 - 04.2024
Quality Control Technician
Nutrabio Labs
09.2023 - 11.2023
CAR-T Manufacturing
Bristol Myers Squibb
03.2022 - 09.2022
Bachelor of Science - Biology
Rowan University
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