Quality Assurance Specialist

Quality Assurance Associate – Manufacturing (On-the-Floor QA)

This role provides Quality Assurance support to GMP manufacturing operations within a regulated biopharmaceutical environment. The position is embedded directly on the production floor, ensuring real-time compliance with cGMP requirements, internal procedures, and regulatory expectations. The role focuses on on-the-floor QA oversight, batch record review, product disposition activities, and investigation support. You will work closely with Manufacturing, Quality Control, and technical teams to ensure high-quality production outcomes and continuous improvement across operations.

• Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, or related discipline
• 0–2 years of experience in a regulated biotech, pharmaceutical, or manufacturing environment
• Foundational understanding of cGMP and regulatory expectations
• Prior exposure to QA, QC, or GMP manufacturing environments

• Experience performing on-the-floor QA oversight
• Experience reviewing executed batch records and GMP documentation
• Exposure to deviation management, investigations, and CAPA processes
• Experience with AQL inspections and line clearance checks
• Ability to collaborate effectively with Manufacturing, QC, and MSAT teams
• Strong attention to detail and documentation accuracy
• Flexibility to support shift work and 24/7 operations

• Start Date:
  
  TBD
• Contract Duration:
  Permanent
• Location:
  
  On-site