AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply. Right. On time. For more information, visit www.agcbio.com .

SUMMARY:

The Quality Control Associate IV- Microbiology will focus on performing complex and routine microbial and environmental monitoring assays, facility qualification studies, testing of purified water and cleaning samples, drafting/reviewing reports and trouble shooting complex issues. This position may also review data, execute validation studies, and support commissioning of laboratory instruments. The ideal candidate will be highly motivated, organized, and have the ability to work independently. Experience in a GMP microbiology laboratory is preferred. This will be a Friday-Monday, Day Shift, 8:00 am- 7:00 pm.

PRINCIPAL RESPONSIBILITIES:

  • 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 reviews.
  • Seeks 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 in drafting technical documents including test methods, validation documents, and deviations.
  • Implement change controls, lead investigations, and complete CAPAs in support of GMP operations.
  • This position will support preparation of quarterly and annual reports, trend investigations, statements
  • quality, and other applicable reports.
  • Trouble shoot complex issues in creative and effective ways as related to standardized company objectives and procedures using professional concepts.

KNOWLEDGE, SKILLS & ABILITIES:

  • Requires knowledge of environmental and utility monitoring programs, compendial microbiological testing (Bioburden, Endotoxin) and testing of water for injection.
  • Experience working in a GMP laboratory.
  • Strong organizational skills in a high-throughput environment.
  • Excellent communication with clear and concise writing & verbal presentation skills.
  • Ability to multi-task and interact well in a team environment.
  • Demonstrated organizational skills and attention to detail.
  • Ability to lift 50 lbs.

EDUCATION/EXPERIENCE:

  • Education: Minimum BS in Biology, Microbiology, or other scientific discipline. Post-Graduate coursework is desirable.
  • Minimum 8 years of related experience in a GMP laboratory or manufacturing role.
  • Strong understanding of Microbiology related to drug substance or drug product manufacturing.
  • Experience with relevant analytical laboratory equipment and software.

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances

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