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.
AGC Biologics is looking for a QS Associate IV with a focus on supplier quality. The primary responsibilities for this role include executing the company supplier quality program supporting a commercial drug substance manufacturing site. This role requires attention to detail, organization, multi-tasking, and comfort interacting with people who might be junior or senior to the incumbent. Works on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
- Execute the AGC Biologics Approved Supplier Program for the manufacturing site.
- Participate in external supplier audits and follow up on audit findings.
- Perform external audits/manage timely performance of audits, i.e. via consultants and other internal qualified resources.
- Collaborate with stakeholders to ensure annual assessment of vendors.
- Manage the assessment of vendor material change notifications and the resulting internal AGC changes, as needed.
- Develop/optimize and maintain supplier corrective action process.
- Work with internal technical authorities and Subject Matter Experts to investigate raw materials discrepancies.
- Manage and track investigations related to raw material/consumable discrepancies.
- Follow up with supplier to ensure investigation progress, as needed.
- Support introduction of new raw materials into the GMP system, and manage materials specification changes.
- Track the approval of new part number requests and material spec changes for multiple projects.
- Create and revise controlled documents.
- Assists with continuous improvement projects related to process workflow.
- Other duties as assigned.
KNOWLEDGE, SKILLS & ABILITIES:
- Strong understanding of cGMP’s and regulatory expectations with regard to raw material supplier controls.
- Demonstrated deep understanding of procedures and methods for review function.
- Experience with external audits for suppliers.
- Demonstrated ability to multi-task and work on several QA projects.
- Ability to work under only general direction.
- Understanding of basic scientific/technical concepts.
- Good problem solving skills.
- Clear, concise technical/regulatory writing skills.
- Good verbal presentation skills.
- Excellent organizational skills and attention to detail.
- Ability to interact constructively with external suppliers.
- BS in Chemistry, Biology or other relevant discipline or equivalent work experience.
- 5+ years QA or related experience working in a regulatory environment or position (GLP, GCP or GMP).
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.