Employment Classification : Regular/Permanent Job details : 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. 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. Adress : Brownsburg