QC Specialist

Orano Med is seeking a detail-oriented QC Specialist to join our Quality Control team. In this role, you'll be responsible for incoming quality control (IQC) activities for raw materials while providing cross-functional support to QC Chemistry operations and managing externally executed raw material testing projects in a GMP pharmaceutical environment.

Routine Functions - QC

• Perform receipt, sampling, testing, and release of raw materials in compliance with GMP, USP, Ph. Eur., and internal procedures.
• Execute compendial and non-compendial testing using approved analytical methods.
• Review data and release materials using established quality systems.
• Maintain raw material specifications, sampling plans, and test methods.
• Manage material status labeling, quarantine, and inventory controls.
• Support and investigate material-related deviations, OOS/OOT results, and discrepancies.
• Serve as QC liaison for external laboratories performing raw material testing, including protocol review, data review, and issue resolution.
• Crosstrain and support routine QC chemistry testing as needed to meet operational demand.
• Maintain GMP documentation, logbooks, and reports.
• Other duties as assigned by Supervisor/Management

Continuous Improvement

• Promote a culture of safety, quality, and continuous improvement across the team.
• Identify process inefficiencies and lead improvement initiatives.
• Maintain strong knowledge of regulatory requirements (21 CFR Parts 11, 210, 211; ICH; USP).

Our Full-Time 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

• and more...

Qualifications Required

Education

• Bachelor's degree in Chemistry or a related technical field.

Experience

• 2-4 years of QC laboratory experience in a GMP-regulated environment, with at least 1-2 years in a Raw Material / IQC environment.
• Analytical instruments: HPLC, ICP-MS, GC, Titration, FTIR, pH/Osmometers, TOC / Conductivity, Endotoxin Testers
• USP methods & ICH guidelines
• Following detailed SOPs; meticulous execution/documentation (GDP)
• QMS in regulated environment

Orano is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, disability, citizenship, veteran status, marital status, sexual orientation, gender identity, genetic predisposition or carrier status or any other characteristic protected by law.