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Analytical Validation Chemist

Company: nxtgen search
Location: Torrance
Posted on: June 21, 2022

Job Description:

- Execute feasibility (pre-validation) studies to support validation experimental design - Translate technical information and requirements into experimental design - Generate, review and execute phrase appropriate method validation/verification/transfer protocols - Prepare documentation in support of the sampling, analysis, and reporting of method qualification or validation results - Perform troubleshooting during method qualification or validation. - Perform data analysis, interpretation and review using statistical methods - Prepare summaries and reports - Compile and track undesirable/unacceptable problems encountered during analytical method execution - Write, review and assist in the evaluation of the effectiveness of SOPs and identify necessary changes following validation activities. Ensures that SOPs are current - Assist in the maintenance of validation/verification/transfer documents - Assist to write risk analysis (or statistical analysis) as part of validation activities; - Monitoring and tracking of validation/verification/transfer activities - May assist with training, competency assessment, and performance evaluations of laboratory personnel as appropriate - Investigate deviations in validation protocols, identify the root cause of the deviation, issue corrective and preventive actions, and carry out follow-up once the actions are implemented to ensure their effectiveness; - Work closely with AD to ensure accurate transfer of methods from AD to QC. - Work closely with QC to ensure accurate scheduling of instrumentation and validation activities - Work closely with QA to ensure documents are reviewed and approved in a timely manner - Work closely with Project Management and the Account Manager to ensure that customer expectations with respect to method validation and transfers are met - Work closely with Regulatory Department to ensure that information is pertinent to method validation are transparent to regulatory - Offer expertise to other departments of the company such as Production, Maintenance, Quality, Engineering and Analytical Services; - Plan and coordinate the activities required as part of the validation protocol with the departments of Production, Maintenance, Quality, Engineering and Stability; - Responsible for continuous evaluation/ optimization of test methods for efficiency and cost reduction - Perform other duties as assigned

--- BSc. in Biotechnology, Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology. Desirable MSc in the above or equivalent--- Minimum of 2 years in Pharmaceutical, Biological or Biotech industry; hands-on experience in pharmaceutical validations, or extensive laboratory experience in wet chemistry/microbiology highly desired.---Thorough experience in computerized systems, data management, process control and fundamental understanding of applied statistics (MS-office, etc.).--- Fluent in English

Keywords: nxtgen search, Torrance , Analytical Validation Chemist, Other , Torrance, California

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