Quality Assurance Associate III Specialist

7 days ago


Copenhagen, Copenhagen, Denmark Exokeryx, Inc. Full time

About Exokeryx, Inc.

We are a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells.

Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in multiple locations. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases.

As a Quality Assurance Associate III at Exokeryx, Inc., you will be responsible for providing quality support to the activities listed below at one of our sites. Your role will include overseeing manufacturing floor operations and reviewing executed manufacturing batch records for completeness, compliance, and accuracy to support product lot disposition.

Key Responsibilities:

  • Review and approve logbook activities
  • Approve equipment and room change-over operations
  • Support review and approval of Master Production Records (MPRs)
  • Conduct review and approval of GMP documents in the electronic Document Management System

You will collaborate in the resolution of issues associated with the manufacturing operations, with the QA point-of-contact, to provide guidance and facilitate the resumption of manufacturing activities post deviation detection.

This position requires a Bachelor's degree in Biology, Chemistry or other relevant science/engineering discipline or equivalent work experience. You should have previous experience in QA or related document control experience, and a minimum of 5 years of experience in a similar role.

The estimated salary for this position is between $74,960 - 103,070 per year, depending on your qualifications and experience.

Please note that this is an overview of the job responsibilities and requirements. For more information, please refer to the company website.



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