Quality Assurance Specialist

  • Regular/Permanent
  • USA / Indiana
  • In Office

Welcome to Orano

Helping to meet current and future challenges to preserve our world and build the world of tomorrow while taking care of everyone's health is stimulating for you. For us too. By joining the Orano Group, a leading international player in the nuclear industry, you are in the right place.

Every day we work to produce efficient low-carbon energy, to fight global warming, to find solutions that save natural resources, and to contribute to progress in health.

Our strengths? Across the entire fuel cycle, we have extensive expertise in cutting-edge technologies, safe, high value-added products and services, and a strong capacity for innovation. All of these factors reflect the strong skills of our 17,000 employees, whom we are constantly striving to develop. With their different backgrounds and experience, they are proof of our openness to all talents. They share the same ambition: to give nuclear energy its full value.

Job description

Orano Med is seeking a detail-oriented Quality Assurance Specialist for radiopharmaceutical manufacturing at ATLab Indianapolis (“ATLab IND”), a new facility for commercial-scale manufacturing of sterile therapeutic radiopharmaceuticals.

The Quality Assurance Specialist will be responsible for supporting GMP manufacturing of raw materials and sterile drugs for clinical trials. The individual in this role will review documentation related to raw materials, components, and completed batch records followed by giving a disposition of each. Assist with quality systems improvements. 

Responsibilities

  • Inspect, review documentation, and release incoming raw materials
    and packaging components.

  • Update Quality SOP’S and perform secondary review of
    documentation.

  • Perform area release for manufacturing, as needed.

  • Oversee sterile manufacturing process, provide sterile gowning and
    practices instruction.

  • Review production batch records, logbooks, and associated
    documentation to assess completeness, accuracy, and compliance
    with SOPs.

  • Review of equipment and instrumentation documentation in support of
    GMP manufacturing and testing operations.

  • Scanning manufacturing documentation such as batch records, raw
    materials, audits, investigations, CAPA, and change control.

  • Release/disposition GMP products for Macrocyclics and OM.

  • Follow up on investigations, CAPAs and change controls for time
    completion.

  • Review of documentation related to technology transfer from R&D for
    manufacturing activities.

  • Perform Internal audits of GMP labs and other non-GMP processes
    as directed.

  • Additional responsibilities as assigned

 

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

Qualifications Required

Education

  • Associate's degree, bachelor’s degree preferred 

Experience

  • 2+ years of quality assurance experience

  • 1+ years of quality assurance experience in Pharmaceuticals or related industry

  • 1+ years of Aseptic Manufacturing

  • Cleanroom: gowning, cleaning, environmental monitoring, and aseptic technique

  • Experience in writing SOPs and other associated GMP documentation.

  • Proficient in Microsoft Office, Excel, and PowerPoint

  • Excellent written and verbal communication skills

  • GMP regulations and compendial guidelines

  • Able to easily switch between multiple ongoing projects, adjusting priorities based on business needs

Physical

  • Stand for 6+ hours
  • Wear cleanroom PPE
  • Preferred Experience

Education

  • BA/BS in a scientific field


Experience

  • Radiopharmaceutical experience
  • FDA: Submission (IND, DMF, NDA); onsite inspections

 

 

Please Note: The provided salary information is a guideline. Your offered salary is based upon experience, qualifications, geographic location, as well as market and business considerations.

 

Salary range annually: $60,000 - $80,000

Orano is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, disability, citizenship, veteran status, marital status, sexual orientation, gender identity, genetic predisposition or carrier status or any other characteristic protected by law. 

Quality Assurance Specialist

Ref: 2025-20877

Regular/Permanent

Brownsburg

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.

Find out more about Orano Med
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