QA Specialist 3, QC Oversight

The Quality Assurance Specialist III supports Quality oversight of the Analytical and Microbiology Laboratories within a fast-paced, regulated cell therapy manufacturing environment.

Requirements

• Provide Quality Assurance oversight of daily operations within the Analytical and Microbiology laboratories
• Review and approve laboratory data packages
• Serve as QA reviewer for analytical and microbiology-related deviations
• Assess and approve change controls
• Perform routine GxP walkthroughs
• Review and approve method validation protocols/reports
• Provide QA representation during internal audits
• Act as QA subject matter expert
• Pulling QC samples from the LN2 and storing IPC samples within the LN2
• Support training and mentoring of QC staff
• Collaborate cross-functionally with QC labs
• Participate in continuous improvement initiatives
• Contribute to risk assessments
• Review of lab system entries
• Provide QA input during method transfers
• Review of laboratory data under cGMP required

Benefits

• Equal employment opportunity employer
• No discrimination against any applicant