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 .
The Quality Control Associate III/IV will provide technical leadership for the LIMS function within Quality Control. This position will create, revise and administer QC LIMS application processes within the Quality Control department. The ideal candidate will be an expert in laboratory operations and developing interdepartmental relationships. This will be a Monday to Friday, Day Shift, 8:00 am- 5:00 pm remote position.
PRINCIPLE JOB DUTIES
- Assist in the implementation and administration of a Laboratory Information Management System (i.e. LIMS LabWare v.8) for Lot Manager, Location Manager, Stability Manager, and Environmental Monitoring
- Create and revise QC Sample plans in LIMS.
- Create and revise LIMS analytical data in LIMS including, QC tests, specifications, Environmental monitoring sites, CoAs, and stability protocols.
- Respond to urgent Mfg/QC LIMS issues in a timely fashion.
- Review and revise Standard Operating Procedures and Master Production records in regards to LIMS functionality.
- Review and approve QC sample plans in the Master Production records.
- Provide training to new LIMS users on functionality.
- Assist with troubleshooting LIMS issues.
- Assist with implementing changes/enhancements in LIMS to address CAPAs and CRs.
- Available to be on call for any urgent LIMS related issues or tasks during evenings/weekends/holidays.
- Work on advanced QC processes and issues that require understanding of the company’s strategies, initiatives, expectations, processes and customer commitments.
- Review QC portions of MBRs for building appropriate LIMS sample plans.
- Understand ICH guidelines related to GMP production of biologics and data systems management.
- Effectively communicate on a timely basis with QC management and team members.
- Represent QC at Internal as required.
KNOWLEDGE, SKILLS & ABILITIES:
- Extensive experience with LIMS and LIMS templating
- Extensive understanding of data integrity requirements for GMP operations, including 21CFR Part 11
- Extensive experience with large scale role out of new laboratory software
- Demonstrated ability to work effectively on cross-functional teams and engage with external clients
EDUCATION & EXPERIENCE
- BS/BA degree and 5-8+ years of relevant experience. Equivalent education and experience may substitute for stated requirements.
- Master’s degree with 3+ years of industry experience. Equivalent education and experience may substitute for stated requirements.
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