Actively hiring for a Sr. QC Analyst with one of our Radiopharmaceutical clients in the greater Indianapolis area!
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)
Qualifications
- 3+ years of QC experience
- 21 CFR Parts 11, 210, 211
- Safety / Waste : laboratory, chemical, hazmat
- Analytical instruments, HPLC, USP methods, ICH guidelines, GMP practices
- Validation of analytical methods
- Inspections : present / defend QC programs
- Following detailed SOPs; meticulous execution / documentation (GDP)
- QMS in regulated environment
Senior QC Analyst - 223758
Training: SOPs, safety (radiation, industrial), on-the-job training for QC methods. QC methods: tech transfer, implementation, improvements, full validation. Top Priority: QC testing for batch release within hours of production. Maintain status as a qualified operator for all QC procedures. ...
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