QC Associate III

CMC Icos Biologics Inc. Seattle , WA 98113

Posted 2 months ago

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 QC Associate I/II/III supports GMP production by testing real time and routine samples in pharmaceutical manufacturing.

PRINCIPAL RESPONSIBILITIES

  • Performs QC analysis and documents activities according to SOPs following good manufacturing processes (GMP) and demonstrates ability to learn QC methods, procedures and systems

  • Performs routine testing to support lot release, stability, and client test requests

  • Supports manufacturing by performing real-time assays like titer and protein concentration

  • Participates in method transfers and validations to bring new products into QC

  • Writes, revises, and collaborates on technical documents such as SOPs, analytical methods, and method attachments

  • Writes quality events, deviations, CAPAs, and change requests and is able to perform investigations to support these quality management systems.

  • Uses small equipment (pH, osmometer) to support laboratory testing

  • Uses a combination of HPLC, UPLC, CE, and iCE3 instrumentation to support laboratory testing

  • Is able to perform a variety of analysis types such as RP, SEC, IEX, Peptide Map, Glycan, icIEF, reduced CE-SDS, and non-reduced CE-SDS.

  • Performs instrument preventative maintenance, troubleshooting, repair, and re-qualification

  • Supports Projects/Initiatives/Team goals by delivering on all assigned tasks

  • Supports the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.

  • Other duties as assigned.

KNOWLEDGE, SKILLS & ABILITIES:

  • Experience (1 - 5+ years) with GMP analytical instruments, including small equipment, HPLC / UPLC, CE-SDS, and controlled temperature units.

  • Understanding of data integrity requirements for GMP operations, including 21CFR Part 11 and GAMP 5.

  • Demonstrated ability to work effectively on cross-functional teams

  • Strong organizational and project management skills, including technical writing and presentation of technical data

EDUCATION/EXPERIENCE:

  • BS/BA degree with 1 - 5+ years of industry experience, or

  • Master's degree with 1 - 3+ years of industry experience. Equivalent education and experience may substitute for stated requirements.

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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QC Associate III

CMC Icos Biologics Inc.