Compliance Specialist - Manufacturing

Role: The Compliance Specialist supports manufacturing projects, quality systems, computer systems, and continuous improvement initiatives within the manufacturing department. Responsibilities: Coordinate project completion, revise and approve manufacturing procedures, lead investigations, manage change control records, assess process performance, assist in training and validation, participate in regulatory inspections, and contribute to tech transfer and process improvements. Represent manufacturing on cross-functional teams, collaborating with QA, QC, Engineering, Validation, and others. Qualifications & Skills: BA/BS in a scientific field or equivalent, 2-5 years in biopharmaceutical manufacturing, familiarity with computer systems (OpCenter, ERP, EBR, Veeva), knowledge of GMP and regulatory standards, strong communication, organizational skills, and proficiency in Microsoft Office. Ability to work evenings, weekends, holidays, and gown for manufacturing areas. Preferred: Lean Six Sigma, root cause analysis, laboratory skills, and experience in ISO 7 cleanrooms. #J-18808-Ljbffr Provident Behavioral Health