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 and cell and gene therapies. 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 Scientist in the Raw Materials (RM) group performs routine and more complicated tasks in support of raw material sampling, testing, and disposition for GMP manufacturing. This position will also participate in QC analytical method trouble-shooting, investigations of OOS/OOT results, and authoring of raw material methods and procedures. The ideal candidate has previous GMP experience in sampling and testing raw materials, commissioning of analytical instruments, technical writing, and experience working in a fast-paced, dynamic environment.

 

PRINCIPAL RESPONSIBILITIES:

  • Support the sampling, testing, and disposition of raw materials in advance of Manufacturing needs: sample GMP materials per documented procedures, perform both routine and complex laboratory testing, review internal and vendor test documentation, and track testing progress against due dates and KPIs.
  • Maintain the laboratory in a GMP inspection ready state: order standards and reagents as necessary, perform scheduled instrument maintenance, maintain current GMP and Environmental Health & Safety (EHS) training, inspect raw material retains, and periodically dispose of samples from dispositioned lots.
  • Support the onboarding of new laboratory equipment and software systems, including user requirement specifications, validation protocols and reports, authoring of operation and maintenance procedures, and data integrity risk assessments.
  • Ensure the GMP compliance within QC raw materials: perform GMP activities as per documented procedures, accurately document all sampling, testing, and instrument maintenance activities, lead laboratory investigations, change control activities and CAPAs, author and review test methods and quality system SOPs, and participate in continuous improvement projects.
  • Coordinate the shipment and testing of raw material samples at contract laboratories, track testing due dates and turnaround times, review contract test lab data, and support laboratory investigations as needed.

 

KNOWLEDGE, SKILLS & ABILITIES:

  • Ability to understand analytical/technical data.
  • Good organizational skills and attention to detail.
  • Experience participating in laboratory investigations of deviations, OOS/OOT results, 5 whys, CAPA, and other quality system functions.
  • Experience in preparing for or participating in laboratory compliance audits and/or inspections by regulatory agencies.
  • Excellent written communication skills and proven ability to translate technical data into concise narrative/summary.
  • Experience working in cross-functional teams.
  • High attention to detail, excellent organizational skills, and ability to work on multiple projects with tight deadlines.

 

EDUCATION/EXPERIENCE:

  • Education: Minimum BS in Biology, Biochemistry or other scientific discipline.
  • Experience: Minimum of 8+ years hands-on experience in a GMP laboratory or manufacturing environment.
  • Experience managing suppliers and/or contract testing laboratories preferred.

 

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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