Quality Assurance Specialist

Orano • Plano, TX

39d • Onsite

About The Position

Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells.

The QA Specialist supports 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.

Requirements

• High Diploma/GED, Bachelor’s degree in science related field
• Have experience in writing SOPs and other associated GMP documentation
• Proficient in Microsoft Office, Excel, and Power Point
• Strong written and verbal communication skills.
• Strong organization skills.
• Able to easily switch between multiple ongoing projects, adjusting priorities based on business needs.

Nice To Haves

• Specific lab experience

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 / instrumentation documentation in support of GMP 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
• Other duties as assigned.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level