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.
Quality Assurance Associate III in the QA Operations group serves as the primary QA reviewer of Manufacturing batch records, QC test data and other documentation supporting GMP operations and product disposition. Additionally, the position supports compliance through in-plant support, internal audits and regulatory inspection support.
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.
Reviews and approves production and testing deviations and investigations.
May review and approve validation protocols, reports and validation deviations.
Reviews and approves Manufacturing and QC SOPs.
Independently interacts with other groups to proactively address compliance concerns and resolve problems.
May participate on client project teams.
May participate on cross-functional compliance improvement projects.
May assist in performing internal audits.
Work the week end shift to support Manufacturing, QC and Engineering operations.
On-call occasionally to provide off-hours support.
KNOWLEDGE, SKILLS & ABILITIES:
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 decisions for operations.
Communicates decisions and recommendations with clear justification to QA group and cross-functional areas.
Independently determines and develops approach to solutions.
Provide solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practicable, and consistent with organization objectives.
Understanding of basic scientific/technical concepts.
Strong understanding of cGMP's and concepts in several quality systems.
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. EOE
CMC Icos Biologics Inc.