Orano Med is seeking a Sr. 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.

• Competitive compensation
• Health, Dental, and Vision insurance - with generous employer contributions
• 401(k) with employer matching and contribution amounts

• Life insurance and Short- and Long-Term Disability insurance provided by the company
• Generous Paid Time Off and holiday schedules
• Numerous Training and Development opportunities

• and more...

All candidates should meet the following minimum requirements in order to be considered for this opportunity:

Qualifications:

Required Experience/Skills:

• 3 years of experience in Quality Control, including 1 year of QC under 21 CFR Parts 11, 210, 211
• Character: integrity, teamwork, customer service, openness
• Exemplify: safety, quality, problem solving, continuous improvement, determination
• Teachable: listen, ask questions, accept feedback; admit mistakes, learn quickly
• Own the QC methods; work with urgency in fast-paced environment
• Execute multiple tasks simultaneously
• 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
• Safety awareness/practices; careful handling
• Excellent technical skills, troubleshooting
• Work with urgency to meet same-day deadlines
• Overcome obstacles to resolve problems quickly, while meeting cGMP standards
• Attention to detail
• Organized work style/space
• Travel <10%
• Lift 50 lbs.

Preferred Experience/Skills:

• Adaptable: Work well leading or following, in a team or independently
• Motivated: Seize opportunities to learn, accept a project, help colleagues
• Radiation safety, OSHA training
• Draft/revise SOPs
• QMS, LIMS
• Gamma spectroscopy
• Microbiology

Education:

BA/BS, Chemistry or related field preferred