Alphanumeric is hiring a QC BIOANALYTICAL ASSOCIATE ANALYST to work in Rockville, MD with our
client of 20 years committed to improving lives through medical and pharmaceutical advancements.
Pay Range: $38.00 - $43.50
Key Responsibilities:
* Perform and document routine testing duties including: GMP potency testing of drug substance and drug product samples for product release and stability; potency comparability and non-GMP studies; testing of manufacturing growth medium components for raw material release; testing by qPCR (for Minute Virus of Mouse), ELISA (for identity, residual host cell protein, residual DNA and residual protein A), cIEF (for identity) Biacore (for identity and binding), SDS-PAGE and Western (for identity and purity). May assist in assay development and optimization activities * Assist with critical reagent and method qualifications, method validation/transfer, lab investigations and assay troubleshooting. * Operate and maintain QC laboratory equipment and instruments in a cGMP-compliant manner. * Work through obstacles; perform and complete routine assignments according to written procedures with supervision. * Perform laboratory duties and safety checks following all safety, GMP, CFR and other regulations in order to assure laboratory compliance. * Evaluate laboratory SOPs and recommends improvement opportunities to maintain compliance with corporate and regulatory guidelines. Revise laboratory SOPs and Work Instructions as assigned. * May participate in the on-call response team for chamber excursions, train as a Self-Inspector Auditor and participates in department Self Inspections and assist with reference standard fill.