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.
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
Schedule
Sunday - Thursday
Hours: 3:00pm - 11:30pm
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.
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
Find out more about Orano Med
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