Orano Med is seeking a Sr. Analyst, QC or Analyst, QC for ATLab Indianapolis (ATLab IND), a new, state-of-the-art facility for commercial-scale, sterile manufacturing of therapeutic radiopharmaceuticals. The top priority for this position will be QC testing for same-day batch release. This position offers the opportunity to help establish a new facility with high standards for quality, volume, speed, and reliability.

Setup Phase:

• Training: SOPs, safety (radiation, industrial), on-the-job training for QC methods
• Assist with IQ/OQ/PQ of new equipment and instrument software; supervise/learn from field engineers when they are on-site.
• Draft/review of documents: SOPs, Forms, FMECA, tech transfer protocol, analytical method validation protocols
• QC methods: tech transfer, implementation, improvements, full validation

Production Phase:

Top Priority: QC testing for batch release within hours of production

Routine Functions

• All tasks from the Setup Phase that continue into Production Phase.
• Safety: Follow EHS regulations/guidelines, incl. NRC (ALARA), OSHA, EPA, chemical, waste disposal, etc.
• Adhere to SOPs, cGMP requirements, company policies, regulatory requirements
• Regulatory compliance: maintain constant readiness for inspection
• Maintain status as a qualified operator for all QC procedures

Day-of-use setup before QC testing:

• Verify calibration/qualification status of instruments
• Gather raw materials and confirm not expired
• System suitability testing of instruments
• Testing:
  • Chemistry QC: raw materials, APIs, in-process materials, finished drug products
  • Microbial: VPHP, inoculation of drug product, incubation/inspection of samples for
  • EM/sterility testing
• Carefully complete documentation: paper/electronic QC test records, equipment logs, other records, perform technical review of completed documents
• Equipment: lookout for failures/concerning trends; report problems; troubleshoot if possible
• Materials: Help receive deliveries; obtain documentation for raw material acceptance; perform in-house testing; coordinate 3rd party testing
• Help maintain backup supplies for QC: spare parts, consumables, PPE, other supplies
• Waste disposal and cleaning of QC lab
• Help recruit/train new employees

Continuous Improvement:

• Embody and promote a culture of quality and continuous improvement
• Strive toward ambitious goals/timelines
• Draft/review SOPs and other documents
• Assist with Quality Events (deviations, OOT/OOS, CAPAs, change controls, recalls, complaints, FMEAs, audits, inspections, investigations)
• Assist with repeating equipment qualification and/or method validation as needed
• Location: On-site 100%

This position may receive other responsibilities as needed.