Quality Control Compliance Specialist

3 days ago


Reston, Virginia, United States INCOG BioPharma Services Full time
Quality Control Compliance Specialist

INCOG BioPharma Services is seeking a highly skilled Quality Control Compliance Specialist to join their team in Indianapolis, IN.

The ideal candidate will have a strong background in analytical and microbiological testing, with experience in GMP regulated industries. They will be responsible for performing in-depth technical data reviews, driving laboratory investigations, and providing SME support for electronic QC database systems.

The Quality Control Compliance Specialist will also be responsible for technical writing, including drafting specifications, protocols, and SOPs. They will work closely with laboratory management to develop analysts and ensure compliance with GMPs.

Key Responsibilities:

  • Perform in-depth technical data reviews of analytical and microbiological testing
  • Drive laboratory investigations and deviations to completion
  • Provide SME support for electronic QC database systems
  • Technical writing, including drafting specifications, protocols, and SOPs
  • Mentor analysts in GMP fundamentals and analytical testing

Requirements:

  • Degree in Chemistry, Biology, or Life Sciences
  • 5-7 years' experience in GMP regulated industry

Why INCOG BioPharma Services?

  • Paid time off and 11 paid holidays
  • 401(k) plan with company match
  • Choice of health and wellness plans
  • Onsite wellness facility
  • Employee engagement activities

At INCOG BioPharma Services, we are committed to creating a culture that values diversity and inclusion. We believe that everyone deserves an equal opportunity to succeed and thrive in their careers.



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