This job is in your area. Enjoy a short commute and work close to home.
Job Description
We are looking for an experienced QC Analytical professional (6β12 years) with strong exposure to analytical testing, data review, and GMP-compliant quality systems in a biopharmaceutical environment.
Key Responsibilities:
β’ Review analytical data for DS, DP, stability, method validation, and method transfer samples.
β’ Perform and review chromatographic and plate-based analytical techniques.
β’ Manage reference standards, laboratory documentation, calibration activities, and inventory.
β’ Handle investigations related to Deviations, OOS, OOT, CAPA, and Change Controls.
β’ Support equipment qualification (IQ/OQ/PQ), analyst qualification, and training activities.
β’ Ensure compliance with GMP, GLP, and GDP requirements.
Technical Expertise Required:
β’ CEX-HPLC, SE-HPLC, RP-HPLC
β’ ELISA, RT-PCR
β’ Capillary Electrophoresis (Maurice System)
β’ Analytical data review and laboratory docu...