Quality Control Manager

Job Description Summary:This position will be responsible initially for QC review of raw data and reports from internal and contracted studies in support of development, including method transfer reports, validation reports, specifications, batch release and stability data, and certificates of analysis. In the future, this position is expected to be responsible for establishing and managing the technical and operational aspects of an internal QC analytical laboratory.Responsibilities:Review analytical data and reports from company and contract sites for development and manufacturing of drug substance and drug product. Interface with process chemistry and manufacturing to ensure successful development and commercializationWork with analytical development and QA to implement procedures in compliance with regulatory requirementsProvide oversight and review of equipment maintenance and calibration activitiesReview regulatory documents, including CMC sections of INDs and NDAsProvide oversight of laboratory testing, including investigations, deviations and troubleshooting conducted in the future QC laboratoryDevelop test protocols, write technical reports and write SOPs for the future QC laboratory operationsReview and approve electronic notebooks and databases such as LIMS and SLIMSTATRequirements:B.S. Degree in Analytical Chemistry or equivalent with at least 10 years experience in the pharmaceutical industry including 3 years of QC ManagementKnowledge of analytical methods applying to small molecules, including but not limited to: HPLC, GC, LC-MS/MS, US pharmacopoeia and wet chemistryKnowledge of cGMP and regulatory requirements or testing, validation, and specification justificationPrior experience with formulation development and manufacturing for parenteral, suspension, capsules and tabletsPrior experience with FDA inspectionsExcellent verbal and written communication skills and the ability to work collaboratively across multiple functional areasExcellent management skills and proven ability to work well with QA to achieve goals. Please contact Thelma Gerome [Click here for email] 858-552-6888 x15
REQUIREMENTS
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