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QC Analyst


Job details

General information

Organization

Orano Med is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the production of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative radioligand therapies which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells. With a solid portfolio of molecules in development capable of targeting various forms of cancer, and a reliable supply chain for Pb-212, Orano Med aims to become a leader in targeted alpha therapies, in particular for patients with currently unmet medical needs.

Find out more about Orano Med  

Location

Job details

Job description (internal)

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

Skills and Qualifications (internal)

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.
 

Employment Classification

Regular/Permanent

Job

P - Production & Operations

Customizable block no. 2

Overtime status

Exempt

Relocation

No

Job location

Job location

America / Caribbean / Canada, USA, Texas

Geolocation by area (Always put 'Yes')

No

Adress

Plano

Additional information

Telework/Home-office

In Office

Applicant criteria

Travel

No

Handled by

Primary manager

Celine LHERITIER