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QC Engineer (Radiopharmaceuitacls)

Indianapolis $35-$40 p/h p/h Contract

Job Responsibilities:

  • Authoring, reviewing, and approving Exceptions, OOSs, CAPAs, Customer Complaints, and Change Controls using a computerized system.
  • Providing direct support for regulatory inspections and customer audits.
  • Ensuring timely and appropriate responses to internal, corporate, customer, and regulatory audits/inspections.
  • Offering support and ensuring the adequacy of responses to regulatory and customer inquiries.
  • Developing robust systems to guarantee cGMP compliance in manufacturing documentation systems, ensuring the quality of documentation, and addressing any remediation needs.
  • Generate, execute, and manage protocols for Method Validations, Equipment Qualifications Work with radioactive materials

  • Reporting and presenting trends to management groups during scheduled review periods.
  • Perform statistical analysis of laboratory data in support of investigations, cost savings, continuous improvement initiatives

Qualifications:

  • Degree in relevant scientific field desired
  • 5+ years of experience in Quality Assurance/Quality Control in a pharmaceutical manufacturing environment
  • 2+ years of experience doing investigations, OOS, CAPAs and change controls
  • Radiopharmaceutical experience strongly desired
  • Proven project management history
  • Demonstrated expertise in root cause analysis tools
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