QC Analyst II - cGMP Chemistry & Radionuclide Testing

Orano; Brownsburg (IN); Presencial; USD 60.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health, Dental, and Vision insurance

401(k) with employer matching

Life insurance

Short- and Long-Term Disability

Generous Paid Time Off

Training and Development

Descripción de la vacante

Orano Med, a subsidiary of Orano USA, is advancing Pb-212-based cancer therapies and leading in radiolabeling technologies. The QC Analyst role involves cGMP testing of products, in-process materials, and stability samples, maintaining labs, and validating methods and equipment.

The position is onsite in Brownsburg, IN, requiring a Bachelor’s in Chemistry or related field and experience in a regulated lab. Competitive benefits and opportunities for growth are offered.

Formación

• Experience in a regulated laboratory environment, preferably pharmaceuticals or biotechnology.
• Proficiency with HPLC, MS, and CE methods.
• Understanding of cGMP, documentation, and data integrity.
• Strong analytical and organizational skills.
• Excellent written and verbal communication abilities.
• Ability to work independently in a team-based setting.
• Ability to adapt to a rapidly changing environment and manage multiple priorities.

Responsabilidades

• 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.
• Review test records, report quality anomalies, and follow established protocols.
• Conduct deviation and laboratory investigations as needed.
• Draft data summaries including COAs and stability summaries.
• Update methods, technical reports, and investigations documentation.
• Prepare testing reagents and maintain laboratory supplies.
• Conduct environmental monitoring sampling, incubation, and testing.
• Assist in validation/development of analytical methods and techniques.
• Participate in QC laboratory equipment qualification.
• Package and send samples to contracted laboratories.
• Additional responsibilities as assigned

Conocimientos

Regulated lab experience

Analytical thinking

Written and verbal communication

Teamwork in a fast-paced environment

Independence and self-motivation

Educación

Bachelor’s degree in Chemistry/Biochemistry/Pharmaceutical Sciences

Herramientas

HPLC

Mass spectrometry (MS)

Capillary Electrophoresis (CE)

Descripción del empleo

Orano Med, a subsidiary of Orano USA, is advancing Pb-212-based cancer therapies and leading in radiolabeling technologies. The QC Analyst role involves cGMP testing of products, in-process materials, and stability samples, maintaining labs, and validating methods and equipment.

The position is onsite in Brownsburg, IN, requiring a Bachelor’s in Chemistry or related field and experience in a regulated lab. Competitive benefits and opportunities for growth are offered.