QA Associate II/III Lot Disposition
Company: AGC Biologics
Posted on: February 24, 2021
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 .
The QA Associate II/III 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.
- 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
- May support in-plant operations (manufacture of biologics) by
conducting in-plant review of MBRs and providing QA support for
Knowledge, Skills & Abilities
- Ability to work on moderately complex problems where analysis
of situations or data requires an in depth evaluation of various
- 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
- Ability to make independent recommendations for routine
- 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
- 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
Keywords: AGC Biologics, Seattle , QA Associate II/III Lot Disposition, Other , Seattle, Washington
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