Primary focus is enhancing systems by which Company assures the safety of our biologic products. Under general supervision, this position will perform routine procedures and testing in support of the Bioanalytics Team.
Responsibilities
Main responsibility will be routine release and stability testing. Preferred qualifications will be experience with ELISA, general Chemistry testing such as pH, Osmo, UV and general reagent preparation.
The QC Senior Associate will also be responsible for documenting, computing, compiling, interpreting, reviewing, and entering data into electronic systems.
Additional responsibilities include providing and communicating results, maintaining/operating specialized equipment, and initiating and/or implementing changes in controlled documents.
Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, laboratory notebooks, written procedures, building monitoring systems and laboratory log books.
Experience with the following GMP systems is also preferred: LIMS, LMES, CIMS and Veeva (cDocs).
Qualifications
Bachelor's degree in Chemistry or Biology & 2 years of experience directly related to the job OR Associate's degree & 4 years of experience directly related to the job.