Senior QC Analyst

  • Regular/Permanent
  • USA / Indiana
  • Telework not possible

Welcome to Orano Med

Orano Med is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the production of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative radioligand therapies which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells.
With a solid portfolio of molecules in development capable of targeting various forms of cancer, and a reliable supply chain for Pb-212, Orano Med aims to become a leader in targeted alpha therapies, in particular for patients with currently unmet medical needs.

Job description

 

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.

Our Full-Time Benefits

  • 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…   

Ideal qualifications

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


Senior QC Analyst

Ref: 2023-13919

Regular/Permanent

Brownsburg

Orano Med is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the production of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative radioligand therapies which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells. With a solid portfolio of molecules in development capable of targeting various forms of cancer, and a reliable supply chain for Pb-212, Orano Med aims to become a leader in targeted alpha therapies, in particular for patients with currently unmet medical needs.

Find out more about Orano Med
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