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Quality Assurance Specialist I

LocationGaithersburg, - None Specified -
Business SectorBiotechnology
Contact email
Job ref26614
Published7 days ago

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

Job Description

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.

Essential Requirements

  • 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

Preferred Requirements

  • 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

Practicalities

  • Start Date: TBD

  • Contract Duration: Permanent

  • Location: On-site

Interested?

Interviews and offers can move quickly. Send your CV to Ana Jiménez at a.jimenez@panda-int.com or call +31 (0)20 2044 502 today to secure your spot in the process.