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
