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Quality Control Process Analyst
2 weeks ago
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Job DescriptionThis role is responsible for ensuring the quality of final products, raw materials, and environmental samples through analysis. The ideal candidate will have strong analytical skills, attention to detail, and excellent communication abilities.
Responsibilities:- Perform complex analytical tests on final product, in-process, and raw material samples to ensure compliance with regulatory requirements.
- Document and review test results to guarantee adherence to current Good Manufacturing Practices (cGMP).
- Operate and troubleshoot high-performance liquid chromatography (HPLC) equipment and other analytical instruments.
- Participate in method transfers, method validation, and technical evaluation activities to support the selection of QC equipment, standards, and reagents.
- Analyze assay trends to identify patterns and update relevant documents accordingly.
- Provide general laboratory support, including housekeeping, equipment maintenance, glassware handling, autoclaving, lab inventory tracking, and ordering lab supplies.
- Lead investigations into out-of-specification (OOS) and deviation incidents, drafting comprehensive investigation reports.
- Bachelor's degree in a relevant field such as chemistry or biology.
- Experience in quality assurance and control.
- Strong analytical skills and attention to detail.
- Excellent communication and interpersonal skills.
- Ability to work effectively in a fast-paced laboratory environment.