Quality Assurance Specialist

Job Title:

Quality Assurance Specialist (Contract) Job Description

The Quality Assurance Specialist will support a state-of-the-art lentiviral vector development and manufacturing facility by overseeing quality documentation for externally manufactured products, managing incoming GMP material release and disposition, and contributing to broader QA activities. This role partners closely with Supply Chain, Manufacturing, and external vendors to ensure product quality, regulatory compliance, and continuous improvement in a dynamic cell and gene therapy environment.

• Perform detailed quality review of executed batch records, manufacturing records, and associated release documentation received from Contract Manufacturing Organizations (CMOs).
• Review manufacturing deviations, investigations, change controls, corrective and preventive actions (CAPAs), and other quality events that impact external batch disposition.
• Evaluate manufacturing and testing documentation to support final external batch release disposition decisions in alignment with cGMP and regulatory expectations.
• Perform quality review and disposition of incoming GMP materials used in the GMP manufacturing facility, ensuring materials meet specifications and are appropriately controlled.
• Support the Vendor Management program by participating in vendor oversight activities and helping ensure vendors meet quality and regulatory requirements, as needed.
• Author, review, and approve Standard Operating Procedures (SOPs) and other controlled documents as a Quality Assurance representative, ensuring documentation is accurate, compliant, and current.
• Collaborate cross-functionally with QA Operations, Supply Chain, Manufacturing, and vendors to resolve issues, support continuous improvement, and maintain alignment on quality standards.
• Work with materials management documentation, including revisions related to out-of-specification (OOS) results, deviations, batch record review, and updates within the ERP system (Net Suite).
• Participate in or support PQ (Performance Qualification) testing and related quality activities, as applicable.
• Communicate effectively with vendors and suppliers, as needed, to clarify quality requirements, address documentation questions, and support timely batch disposition.
• Contribute to the implementation and maintenance of quality management system elements, including risk management practices that support Phase 1 and first-in-human programs.
• Demonstrate a continuous improvement mindset by identifying opportunities to streamline processes, enhance compliance, and improve documentation quality.
• Perform other quality-related duties as assigned to support evolving business and operational needs.

• Bachelor’s degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or another life science discipline.
• Minimum of 5 years of work experience in an FDA-regulated industry, or a similar combination of education and experience.
• Demonstrated understanding of quality management systems and relevant pharmaceutical regulations and regulatory guidance.
• Experience supporting a cGMP biopharmaceutical manufacturing facility within a Quality organization.
• Strong knowledge of current Good Manufacturing Practices (cGMP) and their application to manufacturing and testing operations.
• Hands-on experience with material release, material disposition, and material management in a GMP environment.
• Proficiency in quality review of batch records, manufacturing records, and associated release documentation.
• Experience reviewing and managing deviations, investigations, change controls, CAPAs, and other quality events.
• Familiarity with handling out-of-specification (OOS) investigations and related documentation.
• Experience working with ERP systems, preferably Net Suite ERP, in support of materials management and quality processes.
• Understanding of risk management principles and their application within a quality system, particularly for Phase 1 and first-in-human products and programs.
• Strong communication skills, with the ability to convey complex quality and compliance concepts clearly to cross-functional partners and vendors.
• St…