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/II (Raw Materials) supports GMP production by sampling and testing raw materials used in pharmaceutical manufacturing.
Performs complex and routine laboratory activities in support of GMP Raw Materials testing.
Performs laboratory maintenance activities, including the monitoring of supply inventories and equipment calibration status.
Performs initial assembly of lotfile documentation; verifies required testing.
Performs raw material sampling in a GMP cleanroom environment; documents sample chain of custody information.
Orders supplies and reagents. Maintains laboratory areas.
Works as a member of a fully-integrated team.
Participates in QC analytical method trouble-shooting and in investigations of OOS/OOT results.
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:
0-2 years GMP laboratory experience
Experience with compendial testing of raw materials for pharmaceutical production
Communication skills with the ability to communicate scientific work performed to the team.
Proficiency with MS Excel and Word
Ability to lift and move buckets weighing up to fifty pounds
B.S Chemistry or related discipline
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.