Labs Data Reviewer, GMP, HPLC

Job Description: • Perform review of a variety of routine and complex analytical analysis experiments conducted on pharmaceutical and biopharmaceutical compounds • Ensure analyses are following validated or experimental analytical procedures • Compare results to methodology, protocol and product specifications, Standard Operating Procedures (SOPs) acceptance criteria, and Good Manufacturing Practices (GMP) • Review data entered into databases and reports and monitor the quality of the laboratory data • Evaluate laboratory data for compliance with analytical methods, client directives, and SOPs • Review sample results for scientific soundness, completeness, accurate representation of the data, and final reported results • Communicate with laboratory staff to proactively maintain the quality of laboratory documentation • Deliver review findings noting deficiencies within the analytical data or reports in a clear and concise manner • Escalate significant deficiencies to the project leader or supervisor for assessment • Facilitate conversations with lab staff on best documentation practices and addressing quality findings • Identify and support process improvement initiatives • Perform other duties as assigned 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 and wellbeing support • Work-life balance • Remote work flexibility Apply tot his job