QC Analyst I — cGMP Testing & Method Validation (Onsite)

Orano USA; Brownsburg (IN); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Health, Dental, and Vision insurance –

401(k) with employer matching

Job summary

Orano Med, a subsidiary of Orano USA, is seeking a QC Analyst I to perform cGMP testing of final products, in-process materials, and raw materials in our Brownsburg, IN lab.

You will maintain the laboratory, write and optimize methods, qualify equipment, and draft CofA and stability summaries, ensuring accurate documentation. The ideal candidate has a BSc in Chemistry and pharma/biotech experience, with strong communication and organizational skills.

Qualifications

• Experience in a regulated laboratory environment, preferably pharmaceuticals or biotech.
• Proficiency with HPLC, MS, and CE methods.
• Understanding of cGMP, documentation, and data integrity.

Responsibilities

• Perform comprehensive testing on final products, in-process materials, raw materials, and stability samples.
• Execute chromatography, spectroscopy, wet chemistry, and radionuclide assays.
• Review test records, report anomalies, and maintain documentation per protocols.
• Draft CofA data summaries and stability tables.
• Update methods, reports, and investigations documentation.
• Prepare testing reagents and maintain laboratory supplies.
• Support validation and equipment qualification activities.

Skills

HPLC

MS

CE

cGMPs

Documentation

Data integrity

Analytical skills

Communication

Teamwork

Education

Bachelors in Chemistry

Job description

Orano Med, a subsidiary of Orano USA, is seeking a QC Analyst I to perform cGMP testing of final products, in-process materials, and raw materials in our Brownsburg, IN lab.

You will maintain the laboratory, write and optimize methods, qualify equipment, and draft CofA and stability summaries, ensuring accurate documentation. The ideal candidate has a BSc in Chemistry and pharma/biotech experience, with strong communication and organizational skills.