Position Description

QC Associate I
Location SEATTLE - Bothell, WA
Company Order # 1627
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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 I will perform QC analysis and document activities according to SOPs following good manufacturing processes (GMP).  This individual will also demonstrate the ability to learn QC methods, procedures and systems.

PRINCIPLE RESPONSIBILITIES

  • Perform QC microbiological testing such as bioburden, endotoxin, TOC, Conductivity

  • Performs environmental and utility monitoring.

  • Supports projects / initiatives / team goals by delivering on all assigned tasks

  • Trouble shooting as related to standardized processes and procedures under direct supervision

  • Seeks opportunities for continual learning and improvement

  • Receives close and regular instruction, guidance and direction from others in the form of steps and tasks

  • Participate with test method transfers, qualifications and validations

  • Assist in drafting technical documents including test methods, validation documents, and deviations

  • Assist with the generation of SOPs related to test methods and product release

  • Perform data verification and data entry

KNOWLEDGE, SKILLS & ABILITIES:

  • Good understanding of basic scientific concepts.

  • Good mathematical skills.

  • Clear, concise writing skills.

  • Ability to interact well in a team environment

  • Demonstrated organizational skills and attention to detail.

  • Ability to lift 50 lbs.

    EDUCATION / EXPERIENCE:

  • 0-2 years of relevant experience

  • BS/BA degree in biological sciences (Microbiology, Biology, Biochemistry, etc)

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    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.  EOE

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