Nilam Patel

Detail-oriented QA Operations Specialist with 9+ years of experience in GMP-regulated environments, specializing in documentation control, deviation/CAPA management, and batch record review. Proven ability to collaborate with Manufacturing, QC, and Regulatory teams to ensure product quality, data integrity, and inspection readiness. Recognized for strong problem-solving skills, process improvements, and maintaining high-quality standards in clinical and commercial operations.

Senior Specialist, QA Operations - Bristol Myers Squibb - Warren, NJ

(2025-04)

Provided functional quality assurance oversight for Warren Manufacturing Operations, Supply Chain Operations, Warehouse, and QA/QC laboratory processes in the execution of clinical manufacturing of cell therapy products.

• Actively participated in shop floor and quality check walkthrough programs to ensure compliance and operational excellence
• Revise department SOPs, as well as Review and QA Approval of CTD SOPs
• Perform review/approval of executed batch records and Chain of Identity verification
• Managed the printing, issuance, chain of identity (COI) verification, and reconciliation of finished drug product labels utilized by manufacturing and supply chain operations
• Applied comprehensive knowledge of quality processes, including batch record review, material disposition, deviation triaging, investigations, corrective and preventive actions (CAPA), risk management, change control, and product complaints
• Revised departmental standard operating procedures (SOPs) and conducted review and QA approval of Clinical Trial Document (CTD) SOPs
• Reviewed and approved executed batch records and conducted chain of identity verification to ensure accuracy and compliance
• Oversaw ERP material status changes related to production and drug products
• Maintained up-to-date knowledge of industry standards in relation to current Good Manufacturing Practices (cGMPs) and global regulatory guidelines and requirements
• Collaborated in a team-based, cross-functional environment to achieve business objectives effectively
• Supported risk assessments and projects as required by senior management to enhance operational efficiency
• Served as a backup for approving printed labels and documents prior to their use on the manufacturing floor, ensuring compliance with regulatory standards
• Utilized multiple electronic quality systems, batch records, and Oracle to streamline operations
• Practiced aseptic behavior in controlled areas to maintain product integrity
• Supported process simulations for apheresis, pack-out, and CAPH receipt processes to ensure the sterility of products and processes is uncompromised
• Must possess an independent mindset and have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality Risk Management principles
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution
• Proposes solutions for complex issues and works with management to resolve
• Able to prepare written communications and communicate problems to cross-functional counterparts and management with clarity and accuracy

QA Specialist – Batch Record Reviewer CDMO - Evergreen Theragnostic - Springfield, NJ

(2024-09 - 2025-03)

Provided Quality Assurance oversight for manufacturing, supply chain, warehouse, and QA/QC laboratory operations supporting clinical cell therapy manufacturing.

• Perform review and approval of executed batch records and Chain of Identity (COI) verification to ensure compliance and data integrity
• Manage printing, issuance, reconciliation, and approval of finished drug product labels used by manufacturing and supply chain operations
• Participate in shop floor walkthroughs and quality checks to ensure compliance with cGMP and operational excellence
• Revise departmental SOPs and review/approve Clinical Trial Documentation (CTD) SOPs
• Support material disposition, deviation triage, investigations, CAPA, change control, and risk management activities
• Oversee ERP material status changes related to production and drug product lifecycle
• Support risk assessments and cross-functional projects to improve operational efficiency
• Serve as backup approver for manufacturing labels and controlled documentation prior to production use
• Utilize electronic quality systems, batch record systems, and Oracle to support QA operations
• Maintain compliance with cGMP, regulatory requirements, and global quality standards
• Support aseptic operations and maintain proper behavior in controlled manufacturing environments
• Participate in process simulations including apheresis, pack-out, and CAPH receipt to ensure sterility assurance
• Collaborate cross-functionally with Manufacturing, QC, Supply Chain, and Regulatory teams
• Author and critically review investigations, interpret data, and develop risk-based conclusions