Job description
Orano Med is seeking a detail-oriented QC Analyst - Raw Materials 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
Ideal qualifications
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 employer.
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