QC Lab Supervisor
Quality Control Laboratory Supervisor
- Responsible for overseeing the daily operations of the QC laboratory team.
- Possesses a strong knowledge of analytical instrumentation including HPLC, GC, ICP-MS & ICP-OES.
- Ensures proper workload management to maintain sample flow and timely results to meet Manufacturing needs.
- Stays up-to-date on publications from USP, FDA, and other regulatory bodies, as well as ISO 17025 requirements, to ensure compliance in analytical applications, release specifications, and documentation practices.
- Assists QC Management in compliance audits for the Quality Control Laboratory and contributes to developing strategies to address audit findings.
- Initiates or assists with the review of sourcing, material, and finished product specifications.
- Supports laboratory personnel in resolving Out-of-Specification and Out-of-Trend results, determining scientifically sound re-sampling and retesting procedures, and implementing necessary corrective actions.
- Reviews and signs off on OOS/OOT reports, Certificates of Analysis, and other laboratory reports.
- Ensures laboratory personnel follow proper safety protocols, including the storage, handling, and disposal of hazardous waste in accordance with state and federal regulations. Understands and signs off on waste manifests.
- Undergoes annual training as required by regulating bodies and collaborates with the Safety department to address laboratory hazards.
- Oversees and reviews stability and release testing on raw materials and finished products conducted by laboratory personnel or contract laboratories.
- Ensures adherence to current Standard Operating Procedures (SOPs), in-house test methods, and compendial methods.
- Records all procedures and other records in a timely manner following current Good Manufacturing Practice (cGMP) documentation guidelines.
- Maintains a safe working environment and ensures calibration and proper maintenance of testing equipment.
- Effectively communicates with other departments within the organization and works well in a team environment.
• Prior experience in a supervisory or team leadership role, with at least three years of laboratory experience in a cGMP facility. Familiarity with laboratory instrumentation operations, troubleshooting, and SOP generation and revision, test methods, and Certificates of Analysis.
• Strong interpersonal and self-motivation skills, with the ability to interact with personnel at all levels.
Education and Experience:
• Bachelor of Science (B.S.) or Bachelor of Arts (B.A.) degree in Chemistry or a related science.