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.

Schedule:

• 1^st and 2^nd shift
• Must be flexible
   

• 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.