QC Analyst

Orano Med • Brownsburg, IN

113d • $60,000 - $85,000

About The Position

Orano Med is seeking a detail-oriented QC Analyst to join our Quality Control team. In this role, you will conduct cGMP testing of final products, in-process materials, raw materials, and stability samples. You will maintain laboratories, assist in writing and optimizing methods, perform method validation, and qualify lab equipment as needed.

Requirements

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related technical field.
• Experience in regulated laboratory environment, preferably in pharmaceutical or biotechnology.
• Proficiency with a variety of HPLC, MS, and CE (Capillary Electrophoresis) methods.
• Comprehensive understanding of cGMPs, proper documentation, and data integrity.
• Strong analytical and organizational skills.
• Excellent written and verbal communication abilities.
• Demonstrated ability to work independently in a team-based setting.
• Capability to function effectively in a rapidly changing environment.
• Skill in balancing multiple priorities simultaneously.
• Flexibility to easily switch between multiple ongoing projects and adjust priorities based on business needs.

Responsibilities

• Perform comprehensive testing on final products, in-process materials, raw materials, and stability samples.
• Execute a variety of testing methods including chromatography, spectroscopy, wet chemistry, and radionuclide assays.
• Complete and review test records with accuracy and attention to detail.
• Report any quality anomalies according to established protocols.
• Perform deviation and laboratory investigations as needed.
• 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.
• Additional responsibilities as assigned.

Benefits

• Competitive compensation
• Health, Dental, and Vision insurance - with generous employer contributions
• 401(k) with employer matching and contribution amounts
• Life insurance and Short- and Long-Term Disability insurance provided by the company
• Generous Paid Time Off and holiday schedules
• Numerous Training and Development opportunities

What This Job Offers

• Job Type: Full-time
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree