Senior Quality Assurance Associate

Key Responsibilities

• Execute the Day-to-Day Quality Assurance Tasks to Support Ongoing Manufacturing
• Review and approve executed electronic batch record comments and resolve discrepancies with manufacturing personnel.
• Review and approve executed test results, perform review tasks in the laboratory information management system to issue Certificates of Analysis (COAs) as applicable.
• Provide quality support for manufacturing operations in the cleanroom facilities.
• Be a quality point of contact for process support escalations, troubleshooting, triage and resolution.
• Perform routine hands-on QA activities such as intake of incoming patient apheresis and drug product pack-out activities.
• Compile, review and approve lot disposition records.
• Perform routine raw material disposition and approve raw material specifications.
• Perform review and approval of Deviation, Change Control, CAPA, Excursion and Nonconformance record deliverables, as applicable.
• Promote a culture of safety and GMP compliance.
• Identify opportunities for continuous improvement.
• Support Process and/or Method Qualification and Validation activities by providing quality review of associated protocols, data and reports.
• Perform internal audits as required.
• Support operational excellence initiatives.

Qualifications

• BS degree with 7+ years experience in a relevant field (e.g. biochemistry, chemical engineering, bioengineering, or related scientific field)
• 4-6+ years of experience in GMP biopharmaceutical operations with a minimum of 2+ years in GMP quality
• Proficiency using multiple digital GMP Platforms
• Familiarity with Cellular Therapy manufacturing
• Familiarity with Lentiviral Vector manufacturing