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.
The Senior Manufacturing Compliance Specialist supports Manufacturing activities including deviation investigation and report composition, CAPA creation and closeout, and communication of compliance strategy to stakeholders.
- Perform root cause analysis on manufacturing deviations; create deviation reports.
- Meeting Facilitation and participation, aligning internal review team and area subject matter experts on an agreed to investigational path forward.
- Mentoring and training of Deviation Investigators. Provide investigation guidance and expertise for complex deviation investigations to the team, as well as to associated cross-functional teams in order to drive to root cause of the events.
- 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.
- Routine interaction with the customer, including compilation of Power Points to communicate investigatory current status, Alignment meetings, facilitated reviews, Corrective and Preventative Actions (CAPA) discussions, Comments resolution 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.
- 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.
- Professional and expert technical writing skills.
- Possess excellent meeting facilitation and conflict resolution skills.
- S. in Chemistry, BioChemistry, Biology or related scientific discipline highly preferred.
- Minimum of 7+ years’ experience conducting investigation and root cause analysis in a pharmaceutical or FDA/GMP environment required.
- 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.
- 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.