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 QS Associate IV's primary responsibilities include executing the company supplier quality program supporting a commercial drug substance manufacturing site. Works on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Additional responsibilities for this role include administration of the supplier qualification processes, supporting the creation of new material part codes and related specifications and managing material related change controls and investigations. This role requires attention to detail, organization, multi-tasking, and comfort interacting cross-functionally with internal and external partners. The successful candidate is able to work under minimal direction and possesses the ability to work on complex problems by analyzing procedures and data to create appropriate solutions.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Execute the AGC Biologics Approved Supplier Program for the manufacturing site.
- Help develop the annual audit schedule.
- Schedule audits with suppliers.
- Perform supplier audits and complete audit reports in a timely manner.
- Manage timely performance and closure of outsourced audits, i.e. audits conducted via consultants and other internal qualified resources.
- Manage supplier CAPA follow-up.
- Facilitating initial and lifecycle supplier qualification assessments.
- Manage Approved Supplier List.
- Act as a supplier point of contact for quality related topics.
- Manage the assessment of vendor material change notifications and the resulting internal AGC changes, as needed.
- Work with internal technical authorities and Subject Matter Experts to investigate raw materials discrepancies. Follow up with supplier to ensure investigation progress, as needed.
- Support introduction of new raw materials into the GMP system, and materials specification changes.
- Create and revise controlled documents
- Optimize the Supplier Quality program through management of or participation on continuous improvement projects.
- Supports regulatory inspections as an SME for Supplier Quality.
- May act as a delegate for Manager Supplier Quality Management and other SQM Associates.
KNOWLEDGE, SKILLS, AND ABILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
- Strong knowledge of GMP guidelines as well as international regulations pertaining to the production of APIs and drug products including, but not limited to, ICH Q7, ICH Q10, 21 CFR 210 and 211, 21 CFR Part 11, 21 CFR 600 and 610.
- Understands compendia (USP/NF, PH. EUR., JP).
- Proven technical writing skills.
- Proven ability to perform supplier audits.
- Skill in verbal communications. Ability to respond to complex inquiries or complaints from customers, co-workers and supervisors regarding products and processes.
- Strong knowledge of Quality Assurance concepts related to raw material and supplier management activities.
- Knowledge of and skill in using computer software and hardware applications. Proficiency with Microsoft applications, including MS Word, MS Excel and Teams preferred.
- Skill in time and priority management. Must be able to work under general direction to complete work tasks.
- Demonstrated ability to work collaboratively to accomplish deadlines and objectives.
EDUCATION and/or EXPERIENCE
- Bachelor's degree (B.S.) or equivalent in chemistry, engineering or related life sciences field.
- Minimum 5 years prior working experience in a Biotech/Pharmaceutical production environment is required; preferably with at least 2 years focus on supplier quality.
- Experience with change control principles and execution.
- Experience interacting with FDA or other regulatory agencies strongly preferred.
- ASQ certification or equivalent strongly preferred.
- Experience with TrackWise preferred.
$85,100 - $108,000
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.