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Supervisor, Manufacturing Compliance

Company: AGC Biologics
Location: Seattle
Posted on: May 16, 2022

Job Description:

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 Supervisor, Manufacturing Compliance oversees day-to-day responsibilities of the compliance team, including people management and planning, ensuring compliance with established processes and standards.

Principal Responsiblities

  • Ensure compliance with company quality systems, safety procedures, and other company policies.
  • Plan daily activities, priorities and workflow for Manufacturing as it relates to deviation and CAPA management.
  • Provide training, mentorship, and coaching to staff within the manufacturing team.
  • Represent MFG Compliance at internal and external meetings (e.g. deviation triage, lot disposition, client and supplier meetings).
  • Work closely with Manufacturing operations and Quality Assurance to drive deviations to timely closure.
  • Provide direction to employees according to established policies and management guidance.
  • Prepare and deliver routine reports and communications to site regarding deviation status.
  • Participate in and lead improvement projects for Manufacturing operations and manufacturing compliance.
    Knowledge, Skills & Abilities
    • Ability to understand and apply GMP regulations as they relate to manufacturing and quality management systems
    • Demonstrated ability to apply understanding of how the team relates to other related areas to improve efficiency of own team
    • Solid understanding of the processes, procedures and systems to produce high-quality work on standard problems within the discipline
    • Ability to recognize needed performance improvement and convey feedback in a positive, constructive manner
    • Ability to work across teams effectively
    • Strong technical writing and communication skills
    • Strong computer literacy required
      Education/Experience
      • BS in scientific discipline such as Biochemistry, Chemistry, Biology or related discipline required
      • 5+ years of industry experience required
      • Previous supervisor or manager experience preferred
      • Experience conducting GMP investigations within clinical/commercial manufacturing environment required
      • Experience using quality management systems software (e.g. MasterControl, TrackWise) required
      • 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.

Keywords: AGC Biologics, Seattle , Supervisor, Manufacturing Compliance, Other , Seattle, Washington

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