QC Analyst II

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

Description

Orano Med, a subsidiary of Orano USA, is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the extraction and purification of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative Pb-212-based treatments which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells.

With a solid portfolio of development projects covering a diverse range of biological molecules capable of recognizing and targeting various forms of cancerous tumors, and a reliable supply chain for Pb-212, Orano Med aims to become a leader in targeted alpha therapies, in particular addressing needs of patients currently without effective therapeutic solutions among the existing approaches.

Position Summary

The QC Analyst will be responsible for conducting 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.

Key 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 essays.
• - 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 conduct laboratories

Additional responsibilities as assigned

Requirements

Qualifications

Education

• - Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field

Experience

• - 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
• - Skill in balancing multiple priorities simultaneously
• - Flexibility to easily switch between multiple ongoing projects and adjust priorities based on business needs.

Work Environment

• - Onsite in Brownsburg, IN
• - 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
• - and more…

Present in the United States for 60 years, Orano USA is a leading technology and services provider to the U.S. commercial and federal markets.
Orano’s activities in the U.S. include developing uranium enrichment facility in Oak Ridge, TN ; packages and transportation of uranium & nuclear fuel assemblies ; fabricating & installing used nuclear fuel dry storage canisters and casks, conducting pool-to-pad used nuclear fuel transfers ; providing solutions to the National Labs and to the Dept of Energy ; and supplying U.S. nuclear energy utilities with uranium, conversion, and enrichment services.
In the nuclear medicine field, Orano Med is at the forefront of research in nuclear medicine and is developing a new generation of targeted therapies against cancer using the unique properties of lead-212.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
This position requires a pre-employment background check and drug screening.
Orano is an Equal Opportunity Employer. Orano and all subsidiaries abide by applicable legal requirements. We ensure that all personnel actions such as recruitment, compensation, career development, benefits, and company-sponsored training are administered without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, protected veteran, or other protected status.