QC Analyst II

Orano•Brownsburg, IN

8d•Onsite

About The Position

Orano Med, a subsidiary of Orano USA, conducts nuclear medicine research and develops lead-212-based targeted alpha therapies against cancer. The QC Analyst II conducts cGMP testing of final products, in-process materials, raw materials, and stability samples. The role also supports laboratory upkeep, analytical method writing and optimization, method validation, and qualification of laboratory equipment. This position is onsite in Brownsburg, Indiana.

Requirements

Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a 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.
Ability to function effectively in a rapidly changing environment.
Ability to balance multiple priorities simultaneously.
Flexibility to switch between multiple ongoing projects and adjust priorities based on business needs.

Responsibilities

Perform comprehensive testing on final products, in-process materials, raw materials, and stability samples.
Execute testing methods including chromatography, spectroscopy, wet chemistry, and radionuclide assays.
Complete and review test records accurately and report 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 investigation documentation.
Prepare testing reagents and maintain laboratory supplies and chemicals.
Conduct environmental monitoring sampling, incubation, and testing.
Assist in validation and/or development of analytical methods and techniques.
Participate in qualification of QC laboratory equipment.
Package and send samples to conducting laboratories.
Perform additional responsibilities as assigned.