Quality/Deviation Specialist

About the Role: We are seeking a highly motivated individual with a B.S./M.S. degree in an appropriate engineering/scientific field to join our team. The ideal candidate will have 0-3 years of post-Bachelors degree experience in a cGMP environment within the pharmaceutical/biotech industry. This role will involve providing technical support to manufacturing operations, investigating process deviations, and developing corrective/preventative actions (CAPA). Responsibilities: Provide day-to-day technical support to manufacturing operations Resolve and reduce process deviations. Develop and implement corrective/preventative actions (CAPA). Lead manufacturing and laboratory investigations ,supporting aseptic manufacturing, testing, planning, and release. Utilize sound scientific and engineering principles to investigate process deviations. Troubleshoot and conduct root cause analysis of laboratory test failures and manufacturing atypical events. Education Qualification: B.S./M.S. degree in an appropriate engineering/scientific field Required Skills: Previous experience in writing investigations for atypical events in a manufacturing environment Familiarity with Lean Six Sigma Methodologies Investigational Technical Writing Skills Deviation management authorizing experience