Manufacturing Compliance Specialist I/II

AGC Biologics
Published
September 17, 2022
Location
Boulder, CO
Category
Job Type

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:

AGC Biologics is looking for a Manufacturing Compliance Specialist I/II to support Manufacturing activities including deviation investigation and report composition, CAPA creation and closeout, and communication of compliance strategy to stakeholders.

PRINCIPAL RESPONSIBILITIES:

  • Perform root cause analysis on manufacturing deviations, serving as primary author of deviation reports.
  • Utilize technical writing for the educated but uninformed reader, translate moderate to complex scientific events into a brief and cohesive report as a finished product.
  • Maintain facility GMP compliance; assist in ensuring regulatory inspection readiness.
  • Work closely with other team members to ensure project progression; represent the Manufacturing department's interests on multidisciplinary project teams.
  • Serve as liaison between multiple teams including manufacturing, quality, and process development.
  • Clearly communicate compliance strategy and rationale, both verbally and in written communications.
  • Lead investigations for manufacturing issues, bringing them to a resolution under minimal direct supervision.
  • Initiate appropriate corrective action/preventative action (CAPA) to prevent recurrence of deviations.
  • Work closely with manufacturing operations and QA team to drive CAPAs to timely closure.
  • Facilitate and participate in meetings, aligning internal review team and area subject matter experts on an agreed upon investigational path forward.
  • Work within site quality and asset management systems.
  • Support quality system programs such as Deviation, CAPA, and Change Management.
  • Review records and assist in record closure for Lot Disposition process.
  • Update and revise site manufacturing SOPs.

KNOWLEDGE, SKILLS & ABILITIES:

  • Strong knowledge of FDA and EU regulations for APIs and Drug Products.
  • Ability to understand and apply GMP regulations as they relate to manufacturing.
  • Strong technical writing skills.

EDUCATION/EXPERIENCE:

  • BS in Chemistry, BioChemistry, Biology or related scientific discipline preferred.
  • Minimum of 2+ years' experience conducting investigation and root cause analysis in a pharmaceutical or FDA/GMP environment required.
  • Equivalent education and experience may substitute for stated requirements
  • Ability to read and comprehend complex subjects.
  • Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint), and familiarity with cGMP quality systems.
  • Ability to understand and apply GMP regulations as they relate to manufacturing
  • Experience using GMP compliance in a clinical/commercial manufacturing environment required.
  • Experience using quality management software (Mastercontrol, Trackwise, etc.) preferred.
  • Experience with asset management software (Blue Mountain, Maximo, etc) preferred.

COMPENSATION RANGE

$62,250 - $93,700 annually

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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