QC Chemistry Operations Supervisor
On-siteWest Columbia, South Carolina, United States
Job Summary
Oversee the day-to-day operations of the QC Chemistry Laboratory, including planning resources for sample testing and verifying notebooks, raw data, and COAs before final product release. Manage direct reports through recruitment, training, and performance reviews while drafting and approving SOPs for analytical services. Direct investigations into out-of-specification results and implement corrective actions, ensuring full compliance with FDA, DEA, and cGMP requirements. Establish and report key performance indicators, develop analytical methods, and approve protocols for equipment qualification and stability studies. Provide management approval for final product release and maintain laboratory cleanliness and equipment maintenance.
Required Qualifications
- Knowledge of FDA manufacturing/regulatory quality systems regulations, qualification, facilities and investigation requirements
- Must be detailed oriented and have excellent organizational skills
- Must possess effective written and oral communication skills and be able to handle multiple projects within limited time frames
- Must have skills in HPLC, GC, and mass spectroscopy detection technologies
- Must have excellent communication and technical writing skills
- Minimum Bachelor's degree and/or 5 years of experience working in Quality Control Chemistry and/or Research & Development
- Experience with cGMP documentation systems and with implementation of quality control systems
- Must possess a strong experience base in product QC testing and release procedures and documentation
Desired Qualifications
- Preferred experience in analytical method development, transfer and validation
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