QC Analyst I - cGMP Lab & Method Validation

Orano Med, LLC.; Brownsburg (IN); On-site; USD 52,000 - 70,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) with employer matching

Paid time off

Training opportunities

Job summary

Orano Med LLC in Brownsburg, IN is seeking a QC Analyst I to perform cGMP testing of final products, in-process materials, and raw materials. The role includes maintaining the lab, validating methods, and qualifying equipment, with emphasis on documentation accuracy and data integrity.

You will work with HPLC, MS, and CE techniques, support deviations and investigations, and contribute to stability studies within a fast-paced, compliance-driven environment. Onsite in Brownsburg, IN.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• Experience in a regulated laboratory environment, preferably in pharmaceuticals or biotechnology.
• Proficiency with HPLC, MS, and CE methods.
• Strong documentation and data integrity practices.
• Excellent written and verbal communication abilities.

Responsibilities

• Perform comprehensive testing on final products, in-process materials, raw materials, and stability samples.
• Execute chromatography, spectroscopy, wet chemistry, and radionuclide analyses.
• Prepare Certificates of Analysis (CofA) and stability summaries.
• Maintain laboratory equipment and assist in method validation.
• Draft technical reports and investigations documentation.
• Support environmental monitoring and lab supplies management.
• Collaborate on method development and QC equipment qualification.
• Package and send samples to external laboratories as needed.

Skills

Analytical skills

Documentation

Written & verbal communication

Independence

Adaptability

Education

Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field

Tools

HPLC

MS

CE

Job description

Orano Med LLC in Brownsburg, IN is seeking a QC Analyst I to perform cGMP testing of final products, in-process materials, and raw materials. The role includes maintaining the lab, validating methods, and qualifying equipment, with emphasis on documentation accuracy and data integrity.

You will work with HPLC, MS, and CE techniques, support deviations and investigations, and contribute to stability studies within a fast-paced, compliance-driven environment. Onsite in Brownsburg, IN.