Quality Assurance Technician

Orano Projects Limited; Plano, Northern (TX, KY); Hybrid; USD 70,000 - 100,000; Full time

Benefits offered by this job

Competitive compensation

Health, Dental, Vision insurance

401(k) with employer matching

Life insurance

Paid time off

Training and development opportunities

Job summary

Orano Med is seeking a QA Specialist to support GMP manufacturing of raw materials and sterile drugs for clinical trials. The role involves reviewing documentation, releasing materials, and dispositions while contributing to quality systems improvements across procedures.

This position requires strong writing, attention to detail, and the ability to juggle multiple projects in a fast-paced biotech environment.

Qualifications

• Experience writing GMP documentation and SOPs.
• Proficient in Microsoft Office (Excel, Word, PowerPoint).
• Strong written and verbal communication skills.
• Excellent organizational abilities and project juggling.
• Ability to manage multiple projects with changing priorities.

Responsibilities

• Inspect, review documentation, and release incoming raw materials and packaging components.
• Review production batch records, logbooks, and related documentation for SOP compliance.
• Release/disposition GMP products for Macrocyclics and OM.
• Oversee sterile manufacturing processes and provide gowning instruction.
• Support internal audits, CAPA, and change controls as directed.

Skills

SOP writing

GMP documentation

MS Office

Communication

Organization

Multi-project work

Education

Bachelor's degree in science

Tools

Microsoft Excel

Microsoft Word

PowerPoint

Job description

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.

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 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.

Requirements

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.

Minimum Qualifications:

• High Diploma/GED, Bachelor's degree in science related field

Required Skills and Competencies:

• 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.

Differentiating Qualification(s):

Specific lab experience

• 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...

Present in the United States for 60 years, Orano USA is a leading technology and services provider to the U.S. commercial and federal markets.

Orano's activities in the U.S. include developing uranium enrichment facility in Oak Ridge, TN ; packages and transportation of uranium & nuclear fuel assemblies ; fabricating & installing used nuclear fuel dry storage canisters and casks, conducting pool-to-pad used nuclear fuel transfers ; providing solutions to the National Labs and to the Dept of Energy ; and supplying U.S. nuclear energy utilities with uranium, conversion, and enrichment services.

In the nuclear medicine field, Orano Med is at the forefront of research in nuclear medicine and is developing a new generation of targeted therapies against cancer using the unique properties of lead-212.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

This position requires a pre-employment background check and drug screening.

Orano is an Equal Opportunity Employer. Orano and all subsidiaries abide by applicable legal requirements. We ensure that all personnel actions such as recruitment, compensation, career development, benefits, and company-sponsored training are administered without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, protected veteran, or other protected status.