QC Analyst I – cGMP Chemistry & Analytics

Orano; Brownsburg (IN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

401(k) with employer matching

Life insurance

Short- and long-term disability

Paid time off

Training and development opportunities

Job summary

Orano Med in Brownsburg, IN, seeks a QC Analyst to perform cGMP testing of final products, in-process materials, and stability samples in a regulated lab environment.

You will develop and optimize analytical methods, validate new techniques, and qualify laboratory equipment, while maintaining accurate documentation and data integrity.

Strong collaboration with a cross-disciplinary team, hands-on testing with HPLC, MS, CE, and environmental monitoring will be essential.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• Experience in a regulated laboratory environment preferred in pharmaceuticals/biotech.
• Strong knowledge of cGMPs, documentation, and data integrity.

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.
• 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.

Skills

Analytical thinking

Documentation

Communication

Independent work

Multitasking

Education

Bachelor’s degree in Chemistry/Biochemistry

Tools

HPLC

MS

CE

Job description

Orano Med in Brownsburg, IN, seeks a QC Analyst to perform cGMP testing of final products, in-process materials, and stability samples in a regulated lab environment.

You will develop and optimize analytical methods, validate new techniques, and qualify laboratory equipment, while maintaining accurate documentation and data integrity.

Strong collaboration with a cross-disciplinary team, hands-on testing with HPLC, MS, CE, and environmental monitoring will be essential.