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Senior Quality Assurance Specialist

Quality Assurance
Indianapolis, IN, US
Pay Rate Low: 33.65 | Pay Rate High: 38.46
  • Added - 02/04/2024
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Our client, a pioneer in Therapeutic Radiopharmaceuticals, is now seeking a Senior Quality Assurance Specialist in their new state-of-the-art facility for commercial-scale, sterile manufacturing. This position presents an opportunity to help establish a new facility with high standards for quality, volume, speed, and reliability.


  • 1st and 2nd shift
  • Must be flexible
Pay: $70k-$80k

  • Draft/review/approve SOPs, other QA documents (SVMP, QAAs, FMECA, Risk Analysis)
  • Review IQ/OQ/PQ for new cleanrooms, equipment, software.
  • Tech transfer: PV runs, final report.
  • Vendor qualification
  • Release batch record/QC test records.
  • Manufacturing floor: maintain QA presence; process confirmation.
  • Prompt review of documents for batch release
  • Operational line clearances/AQL inspections
  • Review GMP documents (records, equipment/service logs, certificates)
  • Expert on QMS: speak to management/inspectors.
  • Materials: Inspect; Review COAs/acceptance sheets
  • Work with Production/QC/Shipping teams for mutual improvement.
  • Internal audits, FMEAs
  • Oversee investigations to resolve equipment/process deviations/OOS/recalls/complaints.
  • Coordinate CAPAs/Change Controls; effectiveness evaluation.