Quality Assurance Specialist 3

At MilliporeSigma, as the Quality Assurance Specialist 3, you will perform a variety of tasks within the Quality Assurance department including investigations, deviations, and regulated documentation.Act as the Subject Matter Expert and train new employees in the Investigative Process and techniques.Analyze and evaluate information captured through investigations, communicate findings and recommendations. Review and approve OOS, trend, critical-impact deviations and lower impact events.Conduct trend analysis for deviationsReview / approve applicable CAPA records and conduct Effectiveness checks.Author, review and approve standard operating procedures (SOPs), quality policy documents, and laboratory / batch records.Review and approve assay validation documentation and new GxP service documentation.Review and approve manufacturing documentation including: technical specification, production records, environmental monitoring trends.Negotiate terms of quality agreements for suppliers and customers.Train Quality Specialists and/or Operations teams on quality topics.Review and approve change control (GCC) records.Assist supervisors and managers with team workload assignments.Participate on interview panel for prospective QA team candidates.Lead and/or participate in customer and/or supplier meetings to discuss audit observations, investigations, or negotiate quality agreements.Conduct commission inspections for current, new or renovated laboratories.Act as Quality SME during regulatory inspections and customer audits for areas of expertise.Review and approve study files against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, cell banking production records, and certificates of analysis.Review and approve validation files for systems. Who You Are: Minimum Qualifications:Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, etc.). 4+ years' experience in a Quality role GxP environment.1+ years' experience on investigative process and techniques in a Quality role. Preferred Qualifications:Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity).Experience with reviewing and approving CAPA records, Effectiveness checks and GCC records.Excellent communication and interpersonal skills.Open-minded, flexible and works with agility.