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 www.agcbio.com.
The QC Associate I supports GMP production by testing real time and routine samples used in pharmaceutical manufacturing. Position will be overnight hours on weekend nights to cover the manufacturing schedule.
Responsible for GMP sample management and delivery using LIMS.
Responsible for shipment of samples to clients and vendors.
Assists with activities to support GMP testing in Quality Control.
May be responsible for organizational activities for the laboratory as needed.
Perform regular maintenance on QC equipment like CTUs (freezers and refrigerators)
Perform basic Microbiological GMP testing (Endotoxin and Bioburden)
Responsible for GMP documentation of samples and equipment including receipt and maintenance logbooks.
Position will fill a third shift to cover the manufacturing schedule.
KNOWLEDGE, SKILLS & ABILITIES:
Demonstrates the ability to learn basic procedures and systems as they relate to the QC laboratory.
Very detail oriented and dedicated to complete tasks.
Works on problems of diverse scope and can identify factors that are causing the issue
Exercises judgment within defined practices and is able to problem solve with input from supervisor.
Strong communication, organizational and project management skills.
Education: BS in Science with 2-5 years in an FDA regulated industry
Experience with good documentation practices and/or good record keeping skills are needed.
Experience with laboratory equipment, controlled temperature units, and software systems.
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.