Specialist, QC Analytical
Core
Perform routine testing of in-process, final product, and stability samples, including data review and verification for innovative medicines.
Role type
QC Analytical Specialist
Builds
In-process, final product, and stability samples for pharmaceutical medicines
Domain
Pharmaceutical / Life Sciences
Required skills
cGMP compliance, analytical testing techniques (cell-based assays, flow cytometry, HPLC/UPLC, qPCR, ELISA, aseptic technique), data verification, GMP documentation review, problem-solving
Preferred skills
LIMS/ELN systems, technical writing, method transfer/validation
Technologies
LIMS, ELN, HPLC, UPLC, qPCR, ELISA
Responsibilities
Perform routine testing of in-process, final product, and stability samples; Perform testing for method transfer/validation/verification; Perform data verification, data review and review of GMP documentation; Train analysts on general job duties
Seniority
Mid-level, hands-on IC