QC Analyst II — cGMP Testing & Method Validation

Orano; United States; On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Health insurance (Medical)

Dental insurance

Vision insurance

401(k) with company match

Life insurance & Disability

Paid Time Off

Training and Development opportunities

Job summary

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

You will maintain the lab, optimize methods, validate analyses, and qualify lab equipment. The role requires a Bachelor's in a related field and experience with HPLC, MS, CE, and robust data integrity practices.

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 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.
• Ability to balance multiple priorities and switch between projects.

Responsibilities

• Perform testing on final products, in-process materials, raw materials, and stability samples.
• Execute chromatography, spectroscopy, wet chemistry, and radionuclide methods.
• Review test records and report quality anomalies per protocols.
• Conduct deviations and lab investigations as needed.
• Draft data summaries including CofA and stability tables.
• Update methods, reports, and investigations documentation.
• Prepare testing reagents and maintain lab supplies.
• Conduct environmental monitoring sampling and testing.
• Assist in validation or development of analytical methods.
• Participate in QC equipment qualification and sample shipment.

Job description

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

You will maintain the lab, optimize methods, validate analyses, and qualify lab equipment. The role requires a Bachelor's in a related field and experience with HPLC, MS, CE, and robust data integrity practices.