The QC Lab Supervisor I is responsible for the organization, administration, and supervision of Lab Analysts and other Lab employees; properly overseeing the day-to-day operations by prioritizing shop floor presence and receiving guidance and direction from more senior leaders. Oversees the processes of the chemical analysis and release of raw materials, in-process, and final products in compliance with current quality criteria while respecting deadlines and managing costs. Ensures effective and efficient utilization of laboratory resources through management of laboratory support activities.
Responsibilities
- Responsible for leading and developing a high performing team while prioritizing shop floor presence. This includes hiring, setting performance expectations, providing continuous and on-time performance feedback, coaching staff, assisting in problem-solving, and handling employee matters. Ensures that the department has the appropriate talent and level of performance to meet business objectives. Monitors administration of training, identifies training needs, and ensures development of team.
- Oversees the operation and functions of the laboratory group which may include Raw Materials, Finished Products, Projects/validation samples, MEC, and stability samples. Organizes laboratory activity by coordinating the activity of personnel depending on the demands of planning. Controls the products (raw materials, intermediates, and finished products) by following procedures (general, specific, of analysis and use, and qualification of equipment) to meet the lab testing schedule. Oversees s
- Identifies aspects of the tests or results warranting further attention and implements corrective actions.
- Reviews and approves Analytical data (may relate to analytical product release depending on regional regulatory requirements).
- Supports laboratory investigations, including out-of-specification test results, and ensures effective corrective actions are implemented.
- Effectively understands, communicates, and presents QC Metrics. Attends and leads Tier meetings.
- Ensures appropriate procedures are in place and that QC activities are executed in line with internal procedures, requirements of cGMP, and relevant safety standards. Assists in implementing continuous improvement actions to lab processes.
- Assists analysts with analytical/microbial instrumentation. Assures instrumentation availability to achieve schedule and improves capacity by ensuring that preventive and repair maintenance as well as material qualifications are carried out in a timely matter. Plans the needs of instruments by maintaining permanent technical and technological intelligence. Applies systematic corrections and/or corrective actions that mitigate the risk of recurrent instrumentation failures.
- Assists in the periodic inspection of laboratory facilities to ensure that they are operated and administered according to Good Manufacturing Practices (GMP) and Good Laboratory Practices, maintaining laboratory audit readiness. When required, support supplier, internal, and regulatory audits
- May serve as a backup when the Lab Manager is unavailable. Generates and manages non-hazardous and hazardous waste, according with the internal operating procedures and in compliance with local and federal regulations.