QC Analyst II - cGMP Lab Testing (In-Office)

Orano Med, LLC.; Brownsburg (IN); Presencial; USD 65.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health, Dental, and Vision insurance

401(k) with employer matching

Generous paid time off

Life insurance and disability

Training and development opportunities

Descripción de la vacante

Orano Med in Brownsburg, IN is seeking a QC Analyst II to perform cGMP testing of final products, in-process materials, and raw materials. You will maintain laboratories, help write and optimize methods, perform method validation, and qualify lab equipment.

This in-office role requires strong analytical skills, experience with HPLC, MS, and CE, and a disciplined approach to documentation and data integrity within a fast-changing biotech environment.

Formación

• Experience in a regulated pharmaceutical/biotech lab.
• Proficiency with HPLC, MS, and CE methods.
• Understanding of cGMP, documentation and data integrity.
• Strong analytical and organizational skills.
• Excellent written and verbal communication; ability to work independently.
• Able to balance multiple priorities in a fast-changing environment.

Responsabilidades

• Perform testing on final products, in-process materials, raw materials, and stability samples.
• Execute chromatography, spectroscopy, wet chemistry, and radionuclide assays.
• Review test records and report quality anomalies per established protocols.
• Conduct deviation and laboratory investigations as needed.
• Draft Certificates of Analysis (CofA) and stability summaries.
• Update methods, reports, and investigations.
• Prepare testing reagents and maintain laboratory supplies.
• Conduct environmental monitoring sampling and testing.
• Assist in validation/ development of analytical methods.
• Participate in QC lab equipment qualification.
• Package and send samples to external laboratories.

Conocimientos

Analytical skills

Organizational skills

Written and verbal communication

Team collaboration

Adaptability

Educación

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

Herramientas

HPLC

Mass spectrometry (MS)

Capillary Electrophoresis (CE)

Descripción del empleo

Orano Med in Brownsburg, IN is seeking a QC Analyst II to perform cGMP testing of final products, in-process materials, and raw materials. You will maintain laboratories, help write and optimize methods, perform method validation, and qualify lab equipment.

This in-office role requires strong analytical skills, experience with HPLC, MS, and CE, and a disciplined approach to documentation and data integrity within a fast-changing biotech environment.