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.
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.
Performs independent review of GMP documentation and partners with others for corrections as necessary.
Reviews executed manufacturing batch records for completeness, compliance, and accuracy to support product lot disposition.
Reviews QC data generated from manufactured product and intermediates; approves results summaries.
Creates and reviews documents to be included in DHRs.
May review and approve controlled documents including analytical assays, Standard Operating Procedures, Manufacturing Batch Records, Validation protocols and reports.
Reviews and approves Change Requests, CAPAs and deviations.
Reviews raw material testing to support lot disposition.
Reviews and approves equipment onboarding and preventative maintenance and repair work orders.
Reviews and approves production and testing deviations and investigations.
Support in-plant operations (manufacture of biologics) by conducting in-plant review of MBRs and providing QA support for operations.
Additional responsibilities not listed may be required of this position.
KNOWLEDGE, SKILLS & ABILITIES:
Strong understanding GxPs (GMP preferred) and concepts in several quality systems.
Understanding of basic scientific/technical concepts.
Good analytical skills.
Clear, concise writing skills and good verbal presentation skills.
Excellent organizations skills and attention to detail.
Ability to interact constructively and efficiently with co-workers within and across departments.
Works on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Demonstrates strong understanding of procedures and methods for review function.
Makes independent recommendations for routine operations.
Communicates decisions and recommendations with clear justification tor QA group and cross-functional areas.
Works under only general direction. Independently determines and develops approach to solutions.
Provide solutions to wide range of difficult problems. Solutions are imaginative, thorough, practicable ad consistent with organization objectives.
Solves conflict and addresses workplace issues in professional and collaborative manner.
BS degree in Biology, Chemistry or other relevant discipline or equivalent work experience.
Minimally 4 – 8 years of QA or related experience. An MS degree may partially substitute for work experience.
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. EOE