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 II (Raw Materials) is responsible for sampling, labeling, testing, shipment of raw materials to contract laboratories, and release of incoming raw materials. Additional responsibilities include: performance of material qualification tasks, maintenance of testing documentation for raw materials, and laboratory support through the maintenance of laboratory equipment. The ideal candidate will have experience in GMP compliance, previous experience with GMP testing of raw materials, data review, and understanding of compendial testing (USP, EP, JP, etc.).
- Sample, label, test, send for external testing, and release of incoming raw materials.
- Support laboratory through the maintenance of laboratory, equipment, and test methods per approved procedures.
- Own and drive to completion: quality notifications and tasks in the quality management system (deviations, CAPA, Change Controls, Effectiveness Checks) creation of new documents and document updates.
- Performance of material qualification tasks (testing, report generation).
- Performs simple methods such as physical inspection, pH, and appearance and moderately complex methods such as FTIR, Titration, UV Vis Spectrophotometry, Osmolality, HPLC, GC, and LOD.
- Maintain testing documentation for the QC raw material program.
- Assure that issues are escalated immediately upon noticing.
- Understand critical timelines and assure testing is complete such that there is no business impact.
- Maintain QC laboratories and facilities in audit and inspection readiness mode.
- Maintain inventory of standards and reagents used for routine testing.
- Reviews and verifies QC data.
KNOWLEDGE, SKILLS & ABILITIES:
- Ability to understand analytical/technical data.
- Clear, concise writing skills.
- Good organizational skills and attention to detail.
- Ability to interact constructively with co-workers.
- An understanding of cGMP, CFR, and USP, EP, and JP is required.
- Computer skills (MS Office, MS Excel, MS Project) or comparable word-processing and spreadsheet applications is required.
- BS in Biology, Biochemistry or other scientific discipline required.
- Minimum of 2-4+ years of hands-on experience preferred, or equivalent level of experience.
- Previous hands-on experience with Raw Material assays in a GMP manufacturing environment is preferred
- Previous hands-on experience with methods such as FTIR, Titration, UV Vis Spectrophotometry, Osmolality, HPLC, GC, and LOD in a GMP manufacturing environment is preferred.
Equivalent education and experience may substitute for stated requirements.
$29.93 - $39.50 per hour
Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.
Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.
Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company’s performance and the Team Member’s performance.
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.