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.

IDEAL QUALIFICATIONS

Qualifications Required

EDUCATION

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related technical field.

EXPERIENCE

• Experience in regulated laboratory environment, preferably in pharmaceutical 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.

• 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