Agc Biologics-posted about 1 year ago
$59,758 - $82,160/Yr
Full-time • Mid Level
Boulder, CO
1,001-5,000 employees
Chemical Manufacturing

The Quality Control Associate II at AGC Biologics is responsible for performing microbial and environmental monitoring assays, facility qualification, and testing of purified water and cleaning samples. This role supports the quality control processes in a GMP Microbiology laboratory, ensuring compliance with industry standards while contributing to the development of biopharmaceuticals. The position requires a highly motivated individual who can work independently and collaboratively within a team, focusing on delivering high-quality results in a fast-paced environment.

  • Complete microbiology and environmental monitoring assays, including bioburden, endotoxin, conductivity and total organic carbon (TOC).
  • Perform sampling of water for injection, air, clean steam, compressed gas and facility surfaces in ISO classified manufacturing spaces.
  • Support projects / initiatives / team goals by delivering on all assigned tasks.
  • Perform data verification and data entry.
  • Seek opportunities for continual learning and improvement.
  • Participate in test method transfers and assay validations.
  • Support onboarding and qualification of laboratory equipment and GMP software systems.
  • Assist with the generation of SOPs related to test methods and product release.
  • Support preparation of quarterly and annual reports, trend investigations, statements of quality, and other applicable reports.
  • Serve as a Subject Matter Expert on a particular method, program or discipline.
  • Minimum BS in Biology, Microbiology, or other scientific discipline.
  • 2-5 years Laboratory and/or GMP experience.
  • Strong understanding of Microbiology related to drug substance or drug product manufacturing.
  • Experience working in a GMP laboratory.
  • Experience with relevant analytical laboratory equipment and software.
  • Strong organizational skills in a high-throughput environment.
  • Excellent communication with clear and concise writing & verbal presentation skills.
  • Ability to interact well in a team environment.
  • Demonstrated organizational skills and attention to detail.
  • Ability to lift 50 lbs.
  • Ability to work long hours with physically demanding work, wearing appropriate cleanroom garments and in utility support grey space areas.
  • Highly competitive compensation package
  • Friendly, collaborative culture that values personal initiative and professional achievement
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