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.
Performs QC analysis and documents activities according to SOPs following good manufacturing processes (GMP) and demonstrates ability to learn QC methods, procedures and systems
Performs routine testing to support lot release, stability, and client test requests
Collaborates on technical documents such as SOPs, analytical methods, and method attachments
Uses a combination of small equipment (pH meter, osmometer) and instrumentation (UV spectrometer, SoloVPE) to support laboratory testing
Is able to perform a variety of analysis types such as appearance, pH, osmo, and UV
Performs small equipment preventative maintenance
Supports manufacturing by performing real-time assays like protein concentration
Provides laboratory support by making solutions, ordering reagents, and performing inventory
Supports Projects/Initiatives/Team goals by delivering on all assigned tasks
Supports the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
Other duties as assigned
KNOWLEDGE, SKILLS & ABILITIES:
Some experience (minimum 1 year) with equipment and instrumentation
Some experience (minimum 1 year) with GMP experience and data integrity
Demonstrated ability to work effectively on cross-functional teams
Strong organizational and project management skills, including technical writing and presentation of technical data.
BS/BA degree with 1+ years of industry experience
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.