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Quality Validation Specialist II

4 months ago

Indianapolis, United States Harba Solutions Inc. Full time

In collaboration with the Manager of Quality Assurance for Quality Control, the Quality Validation Specialist will ensure the site adheres to regulations, industry standards (such as ISPE, PDA, ASTM), and organizational SOPs. Additionally, they will be pivotal in fostering and developing a culture that values quality, efficiency, meticulous attention to detail, and timely delivery. The role involves identifying and addressing operational and quality gaps.


Essential Job Functions

The Quality Validation Specialist will support various functions including:

  • Reviewing and approving lifecycle documents
  • Reviewing and approving protocols
  • Reviewing and approving summary reports
  • Reviewing and approving change controls
  • Review various documentation for compliance and quality approval, including commissioning and validation protocols and reports for equipment, software, facilities, utilities, and laboratory equipment.
  • Provide quality oversight for the periodic qualification evaluation (PQE) program to ensure timely execution and documentation.
  • Use technical skills and applied statistics to analyze deviations and identify sources of variability and errors in site processes.
  • Manage multiple projects in a fast-paced environment.
  • Provide support during standard business hours (8 AM – 5 PM, Monday-Friday) and as needed outside of these hours.


Job Requirements:

  • A Bachelor's Degree in a related science field (such as Chemistry, Biology, Biochemistry, Microbiology, etc.) is required.
  • At least 2 years of biopharma industry experience with increasing responsibilities in commissioning, qualification, and validation.
  • Excellent written and verbal communication skills.
  • General computer skills, including experience with computerized operations equipment (such as SCADA) and data analysis software (such as Word, Excel, Visio, JMP, Minitab, etc.).

Additional Preferences:

  • Experience in executing or overseeing CQV activities for FDA/EMA regulated facilities.
  • Experience with CQV activities for aseptic manufacturing facilities or clean utilities
  • Experience using electronic validation execution systems