Quality Lab Supervisor

• Provide support for daily operation of the laboratory and control of workflow. Implement testing standards and policies.
• Conduct regular performance and development discussions with direct reports, provide timely and constructive feedback, establish and document performance improvement plans when appropriate, and monitor progress to ensure sustained improvement and accountability.
• Supervise safety measures of laboratory. Assist personnel and enhance their performance.
• Ensure completion of all testing, including special project / protocol testing in a timely and appropriate manner.
• Assist in implementing quality and regulatory requirements (e.g., FDA, GLP, QSR, cGMP, and USP rules and guidelines), and ensure compliance with testing SOPs and specifications.
• Monitor the testing techniques and accuracy of all records and documentation in the laboratory.
• Participate in pro-active functions that impact production, increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.
• Ensure employees are properly trained. Make appropriate staffing decisions.
• Prepare, review, and revise, as required, SOPs, specifications, and associated training materials; communicate changes and ensure required training updates are completed and documented.
• Ensure equipment maintenance and calibration, and internal audits are performed on schedule.
• Lead out-of-limit and laboratory investigations, identify root causes and corrective actions, and document investigation outcomes accurately and promptly in the TrackWise system.
• Review and approve laboratory records, test results, investigations, and related documentation to ensure accuracy, completeness, data integrity, and compliance with approved procedures.
• Mentor and develop laboratory analysts by providing technical coaching, troubleshooting guidance, performance feedback, and support for training and qualification activities.
• Communicate proactively with Manufacturing, Quality, Engineering, Supply Chain, and other support functions regarding testing priorities and delays, out-of-limit or atypical results, laboratory safety concerns, and potential product or production impacts; coordinate timely escalation, investigation support, and follow-up actions through resolution.

Work Environment / Working Conditions

• ***This position requires work in a facility that manufactures penicillin products; therefore, candidates Must not be allergic to Penicillin and Cephalosporin or their related products and /or materials.***
• May be required to wear appropriate personal protective equipment (PPE).
• Exposure to pharmaceutical materials, chemicals, and manufacturing environments.