Quality Assurance Specialist

We are seeking a highly motivated Quality Assurance Specialist II to join our team and help ensure compliance with quality objectives and regulatory requirements in a fast-paced biopharma environment.

• Perform QA-related production activities, including batch record review, line clearance, and on-the-floor support
• Provide QA oversight for QC activities (
  method transfer, Certificate of Analysis, stability
  )
• Approve shipments and oversee product packaging
• Ensure timely closure of deviations, CAPAs, change controls, laboratory investigations, and batch/material holds
• Conduct walk-throughs and process observations to ensure GMP compliance
• Support regulatory inspections and maintain document control/training records
• Escalate compliance risks and issues affecting product release
• Generate and update procedures and forms as needed

• Background in analytical, virological, or microbiological QC
• Strong knowledge of U.S. and EU GMP standards
• Experience with Veeva, Smartsheet, and LIMS preferred
• Excellent interpersonal, verbal, and written communication skills
• Comfortable working in a fast-paced, dynamic environment

• Master’s Degree OR
• Bachelor’s Degree + 2+ years of experience in biological sciences OR
• AA Degree + 4+ years’ experience OR
• High School Diploma + 5+ years’ experience

If you have a hands-on QA background in a GMP manufacturing environment and thrive in a collaborative, high-compliance setting, we’d love to hear from you!