Quality Assurance Specialist

Regular/Permanent
USA / Texas

In Office

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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 Theranostics:

Are you passionate about ensuring the highest standards in pharmaceutical manufacturing? Do you thrive in a fast-paced, detail-oriented environment where your work directly impacts clinical trial success? Join our Quality Assurance team as a QA Specialist and play a vital role in safeguarding the integrity of raw materials and sterile drug products. Whether you're beginning your QA journey or seeking your next challenge, this is your chance to grow within a dynamic, mission-driven organization that’s transforming oncology from the inside out.

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.

Key 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 practice 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

Work hours vary, start times possible as early as 12AM.

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 must meet the following minimum requirements in order to be considered for this opportunity. Candidates who exceed minimum qualifications may be considered for a higher-level position.

Education & Experience

Associate's Degree in a scientific or technical discipline
0-3 years in the pharmaceutical or related industry

Required Skills & Competencies

Experience writing and revising SOPs
Strong understanding of GMP and sterile manufacturing practices
Experience reviewing batch records and quality documentation
Proficient in Microsoft Office (Word, Excel, PowerPoint)
Excellent written and verbal communication skills
Highly organized and detail-oriented
Ability to manage multiple priorities and adapt to changing demands

Preferred Skills & Competencies

Bachelor's Degree
2–3 years' experience in sterile manufacturing
Familiarity with CAPA, change control, and internal audit processes
Knowledge of technology transfer documentation from R&D
Prior experience with sterile gowning and aseptic technique instruction
Experience with document archiving systems and electronic quality management tools

Orano Med Theranostics is an Equal Opportunity Employer. We welcome all qualified applicants regardless of race, gender, identity, background, or ability.

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: 2026-22686

Regular/Permanent

Plano

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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