Quality Assurance Specialist

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...

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.