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QC Analyst

Orano Med, LLC.
life insurance, vision insurance, paid time off, 401(k)
United States, Texas, Plano
700 Klein Road (Show on map)
Apr 11, 2025
Job description

Orano Med is seeking a detail-oriented QC Analyst to join our Quality Control team. In this role, you will conduct cGMP testing of final products, in-process materials, raw materials, and stability samples. You will maintain laboratories, assist in writing and optimizing methods, perform method validation, and qualify lab equipment as needed.

Key Responsibilities

  • Perform comprehensive testing on final products, in-process materials, raw materials, and stability samples
  • Execute a variety of testing methods including chromatography, spectroscopy, wet chemistry, and radionuclide assays
  • Complete and review test records with accuracy and attention to detail
    Report any quality anomalies according to established protocols
  • Perform deviation and laboratory investigations as needed
  • Draft data summaries including Certificates of Analysis (CofA) and stability summary tables
  • Update methods, technical reports, and investigations documentation
  • Prepare testing reagents and maintain laboratory supplies and chemicals
  • Conduct environmental monitoring (EM) sampling, incubation, and testing
  • Assist in validation and/or development of analytical methods and techniques
  • Participate in the qualification of QC laboratory equipment
  • Package and send samples to contract laboratories
  • Additional responsibilities as assigned
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

Requirements

  • Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field
  • Experience in a regulated laboratory environment, preferably in pharmaceuticals or biotechnology
  • Proficiency with a variety of HPLC, MS, and CE (Capillary Electrophoresis) methods
  • Comprehensive understanding of cGMPs, proper documentation, and data integrity
  • Strong analytical and organizational skills
  • Excellent written and verbal communication abilities
  • Demonstrated ability to work independently in a team-based setting
  • Capability to function effectively in a rapidly changing environment
  • Skill in balancing multiple priorities simultaneously
  • Flexibility to easily switch between multiple ongoing projects and adjust priorities based on business needs

What We Offer

  • Collaborative and innovative work environment
  • Opportunities for professional growth and development
  • Competitive compensation and benefits package

Orano Med is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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.
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