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.Summary
The QA Associate I/II
will support AGC Biologics operations by reviewing all inputs necessary to execute the disposition of the batches manufactured at the site. Such inputs may include: Manufacturing Batch Records (MBRs), analytical test results (i.e. Certificate of Analysis (CoA)), environmental and utilities data, closure of deviations, assessments of Change Records, among others.
It is expected from the QA Associate II to participate in and even drive the solution of issues associated to the batches under their responsibility by interacting with cross-functional teams and providing guidance to assure decisions are aligned with the cGMP regulations, AGC Biologics standards, and clients' expectations per the corresponding Quality Agreement.Principle Responsibilities
Knowledge, Skills & Abilities
- Perform independent review of GMP documentation and partners with others for corrections as necessary.
- Review executed manufacturing batch records for completeness, compliance, and accuracy to support product lot disposition.
- Review QC data generated from manufactured product and intermediates; approves results summaries.
- Create and review documents to be included in DHRs; Bill of materials, flow charts (geneology), raw material lists, etc.
- May review and approve controlled documents including analytical assays, Standard Operating Procedures, Manufacturing Batch Records, Validation protocols and reports.
- May review and approve Change Requests.
- Review raw material testing and release to support lot disposition.
- May support in-plant operations (manufacture of biologics) by conducting in-plant review of MBRs and providing QA support for operations.
- Ability to work on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
- Ability to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Demonstrated strong understanding of procedures and methods for review function.
- Ability to make independent recommendations for routine operations.
- Ability to communicate decisions and recommendations with clear justification for QA group and cross-functional areas.
- Ability to work under only general direction. Independently determines and develops approach to solutions.
- Ability to provide solutions to wide range of issues and/or situations. Solutions are thorough, practicable and consistent with organization objectives.
- Ability to resolve conflict/addresses workplace issues in professional and collaborative manner.
- Ability to develop strong understanding GxPs (GMP preferred) and concepts in several quality systems.
- Understanding of basic scientific/technical concepts.
- BS degree in Biology, Chemistry or other relevant discipline or equivalent work experience.
- Experience working in a regulated environment preferred; previous experience in quality a plus.
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.