Labs Data Reviewer, GMP, HPLC

Job Description: • Performs review of a variety of routine and complex analytical analysis experiments on pharmaceutical and biopharmaceutical compounds • Ensures analyses follow validated or experimental analytical procedures • Reviews data entered into databases and reports • Monitors the quality of laboratory data • Evaluates laboratory data for compliance with analytical methods, client directives, and SOPs • Reviews sample results for scientific soundness, completeness, accurate representation of the data, and final reported results • Communicates with laboratory staff to maintain the quality of laboratory documentation • Delivers review findings noting deficiencies within the analytical data or reports • Escalates significant deficiencies to the project leader or supervisor for assessment • Identifies and supports process improvement initiatives Requirements: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years) • Demonstrated experience of HPLC data review and Empower strongly preferred • Previous experience in GMP regulated laboratory environment preferred strongly preferred • Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP • Thorough knowledge of chromatography • Strong technical knowledge including an understanding of laboratory procedures, methodology, and standards • Strong verbal and written communication skills • Strong attention to detail • Ability to balance time and remain focused on work to meet goals • Ability to train staff on basic review techniques • Ability to independently review laboratory reports and analytical methods • Ability to deal with multiple and changing priorities • Ability to provide clear and concise feedback and/or documentation of results • Ability to work in a collaborative team environment • Ability to work efficiently in a remote capacity Benefits: • Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development