Contract position: A Compliance Specialist is needed for a leading pharmaceutical manufacturer in the Marietta, PA area. This position will lead deviation investigations, initiate deviations, identify root cause through root cause analysis (RCA) and determine CAPAs. No per diem. Responsibilities for the Specialist
Requirements for the Specialist
- Lead cross functional team to investigate deviations. Initiate deviations using a qualified system such as SAP and prepare clear, concise reports from outcome of investigations.
- Perform root cause analysis, using RCA tools. Determine robust corrective actions and / or commitments. Interact and coordinate with appropriate personnel including manufacturing, QA/QC, regulatory, technical services, etc.
- For RCA or per business needs, review of records to include batch documentation, training records, calibration records, standard operating procedures, regulatory policies, testing and manufacturing specifications, validation documents, and other technical documents.
- B.S or B.A in a technical discipline, preferrably Microbiology, Biology/Virology, Biochemistry, Chemistry or Pharmacy. Degree in other discipline if sufficient technical depth has been achieved from professional experience for the job purpose
- Minimum of 1+ years pharmaceutical experience investigating manufacturing deviations either in a QA or manufacturing role; preferably in Biologics Secondary Manufacturing
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.