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.
SUMMARY: AGC Biologics is seeking an energetic and highly motivated associate to join the QA Operations group as part of the lot disposition team. This role serves as a primary QA reviewer of Manufacturing batch records, QC test data and other documentation supporting GMP operations and API lot disposition. Additionally, the position supports compliance through in-plant support, internal audits and regulatory inspection support.
Release of raw materials (consumables and chemicals)
Review and approval of Material specification documents
Review and approval of QC documents (stability)
Ability to provide cross-functional support for QA lot disposition and in-plant processes including but not limited to manufacturing record review, review and approval of controlled documents (SOPs, Change Requests), creation and review of QA records included in DHR, etc.
Applicants must be authorized to work in the United States. If you are legally authorized to work in the United States now, or in the future without any form of sponsorship, we encourage you to apply.
BS degree in Biology or Chemistry preferred, or combination of education and experience o Experience working in a regulated environment with knowledge of GMP or GCP preferred. o Understanding of basic scientific/technical concepts. o Detail oriented team player with effective planning, organization and execution skills o Experience with various Computer skills (Excel®, Word®, Power Point®) o Excellent organizations skills and attention to detail. o Ability to interact constructively and efficiently with co-workers within and across departments. o Demonstrates strong understanding of procedures and methods for review function. o Communicates decisions and recommendations with clear justification tor QA group and cross functional areas. o Solves conflict and addresses workplace issues in professional and collaborative manner o Clear, concise writing skills and good verbal presentation skills.
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.