Jay Patel
Parlin
Summary
Quality Assurance professional with experience supporting GMP manufacturing and clinical development programs within pharmaceutical and biotechnology environments. Proven expertise in batch record review, deviation investigation, SOP governance, audit support, and risk-based quality decision-making. Recognized for providing strong quality oversight across multiple programs while maintaining regulatory compliance, data integrity, and inspection readiness.
Overview
4
4
years of professional experience
Work History
Quality Assurance Specialist
Merck
04.2024 - Current
- Provide comprehensive quality oversight for GMP manufacturing batch records and associated documentation, including raw material confirmations, analytical specifications, certificates of analysis, stability data, and method documentation to support compliant product release and regulatory filings.
- Serve as a primary quality approval gatekeeper across multiple concurrent clinical and development programs, ensuring uninterrupted operations and consistent application of GMP standards.
- Apply risk-based decision-making to identify critical data discrepancies early, safeguarding data integrity and maintaining a high level of audit readiness.
- Classify, investigate, and resolve deviations in accordance with GMP requirements, driving timely closure and regulatory compliance.
- Partner cross-functionally to review and approve technical documentation, including method validations and stability studies, supporting program milestones and future regulatory submissions.
- Provide technical guidance on clinical test method updates, method transfers, and validation protocols, enabling efficient workload distribution and consistent quality execution across teams.
- Author, review, and approve SOPs and GMP documentation to maintain inspection readiness and standardized quality practices.
- Support internal, divisional, and health authority audits by preparing documentation, responding to auditor inquiries, and addressing audit observations.
- Conduct laboratory walk-throughs to verify adherence to GMP procedures, operational controls, and data integrity expectations.
Microbiologist
Nutrabio Labs
11.2023 - 04.2024
- Enhanced product safety by conducting microbiological tests for contaminants.
- Supported quality decisions through accurate dilution and contamination level quantification.
- Resolved microbiological deviations, implementing corrective actions for GMP compliance.
- Developed and updated SOPs for microbial testing and laboratory practices.
- Maintained compliant laboratory records and generated reports per GMP standards.
- Evaluated laboratory cleanliness through ATP testing and environmental monitoring.
Quality Control Technician
Nutrabio Labs
09.2023 - 11.2023
- Conducted chemical and physical testing on raw materials, in-process samples, and finished products in compliance with cGMP and standard testing procedures.
- Maintained calibration and performance of quality control equipment to ensure reliable and accurate results.
- Reviewed analytical data, identified deviations, and documented findings in a timely and compliant manner.
- Supported compliance with federal and state regulations, company specifications, and safety requirements.
- Performed defect analysis and evaluated quality trends to support continuous improvement initiatives.
CAR-T Manufacturing Associate
Bristol Myers Squibb
03.2022 - 09.2022
- Enhanced CAR-T cell production efficiency through effective cell culture techniques.
- Monitored viable cell counts, ensuring high product quality throughout production.
- Executed bioreactor sterilization and managed startup and shutdown processes efficiently.
- Ensured compliance with GMP by maintaining accurate documentation and production records.
- Applied aseptic techniques in cleanroom environments, achieving ISO 7 gowning compliance.
- Conducted environmental monitoring and performed aseptic welding in accordance with GMP standards.
Education
Bachelor of Science - Biology
Rowan University
Glassboro, NJSkills
- GMP / cGMP Compliance
- Batch Record & Documentation Review
- Deviation Classification & Investigation
- SOP Authoring, Review & Approval
- Audit & Inspection Support
- Data Integrity (GDP)
- Regulatory & Technical Documentation
- Risk-Based Quality Decision Making
- Microbiology & Environmental Monitoring
- Cleanroom & Aseptic Operations
Timeline
Quality Assurance Specialist
Merck
04.2024 - Current
Microbiologist
Nutrabio Labs
11.2023 - 04.2024
Quality Control Technician
Nutrabio Labs
09.2023 - 11.2023
CAR-T Manufacturing Associate
Bristol Myers Squibb
03.2022 - 09.2022
Bachelor of Science - Biology
Rowan University