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Sr. Quality Control Analyst-Cell Biology
By | April 28, 2008
PROVEN Scientific Practice is currently recruiting for a Sr. QC Analyst to work with a company developing a gene therapy technology to treat major neurodegenerative disorders. The successful candidate will be responsible for release testing in support of non-clinical and clinical viral vector products in compliance with GXP requirements. Establishing, modifying, and following standard operating procedures (SOPs); performing release, stability, and in-process testing of materials, samples, and final products; works with mammalian tissue samples and cultures. Performs analysis and interpretation of test results, identifies deviations, and makes appropriate recommendations. Provides guidance to junior staff and applies technical and regulatory compliance knowledge daily.
Requirements include a relevant scientific degree with minimum 5 years related experience in bio-pharma analytical laboratory. Experience in quality control strongly desired. Experience with viral vector (adeno-associated virus) product is a plus. Knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industries is required. Must have laboratory experience with a variety of analytical techniques including, but not limited to, quantitative PCR, ELISA, and cell-based assays. Proficient in general and non-routine laboratory skills. Good oral and written communication skills. MS Office skills; equipment related software such as Soft Max Pro desired.
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