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.
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
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.
Please Note: The provided salary information is a guideline. Your offered salary is based upon experience, qualifications, geographic location, as well as market and business considerations.
Salary range annually: $60,000 - $85,000