Quality Assurance Specialist II

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 II 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 QA Specialist II supports GMP manufacturing operations by reviewing documentation, inspecting materials, and ensuring compliance with SOPs and regulatory standards. This role plays a key part in maintaining quality systems, supporting sterile manufacturing, and driving continuous improvement across QA processes.

Key Responsibilities

• Review and inspect documentation for incoming raw materials and packaging components
• Release/disposition GMP products for Macrocyclics and OM
• Conduct thorough reviews of production batch records, logbooks, and associated documentation
• Perform area release for manufacturing operations
• Oversee sterile manufacturing processes and provide instruction on sterile gowning and aseptic techniques
• Review equipment and instrumentation documentation supporting GMP operations
• Scan and archive manufacturing documentation (e.g., batch records, audits, investigations, CAPAs, change controls)
• Follow up on investigations, CAPAs, and change controls to ensure timely and compliant resolution
• Participate in internal audits of GMP labs and non-GMP processes
• Assist in updating Quality SOPs and perform secondary documentation reviews
• Support documentation review related to technology transfer from R&D

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...

Education & Experience

• Education: Bachelor's Degree in a scientific or technical discipline
• Experience: 2-5 years in the pharmaceutical or related industry, including 2-3 years in sterile manufacturing is preferred

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

• 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.