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

Schedule: Monday - Friday/2nd shift

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.