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Quality Validation Specialist

Indianapolis 75K - 90K Permanent

Job Responsibilities:

  • Review documentation for compliance and Quality approval, including but not limited to: equipment and software (process equipment, computerized systems, facilities, utilities, laboratory equipment as needed) commissioning
  • Reviewing/Approving IQ/OQ/PQ protocols and reports
  • Reviewing/Approving Equipment and software validation lifecycle documents (e.g. URS, TM, etc.)
  • Reviewing/Approving Cleaning validation protocols and reports
  • Reviewing/Approving process validation protocols and reports.
  • Provide Quality oversight to the periodic qualification evaluation (PQE) program to ensure timeliness of execution and documentation completion.
  • Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes.
  • Ability to manage multiple projects in a fast-paced environment.
  • Provide support during normal hours (8 AM – 5 PM Monday-Friday) and after business hours as needed.


Qualifications:

  • Bachelor’s Degree required; degree preferred to be in a related Science (Chemistry, Biology, Biochemistry, Microbiology etc.).
  • Minimum of 2 years of biopharma industry experience with increasing responsibilities in Commissioning, Qualification, and Validation.
  • General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).  
  • Experience with executing or providing oversight for CQV activities for FDA/EMA regulated facilities.
  • Experience with CQV activities for aseptic manufacturing facilities or clean utilities (e.g. Water for Injection, Clean Steam, etc.).
  • Experience utilizing electronic validation execution systems (e.g. KNEAT, ValGenesis). 


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