Laboratory Supervisor

SUMMARY The Laboratory Supervisor is responsible for overseeing day-to-day laboratory operations, personnel, reagent production, validation activities, quality compliance, and laboratory safety.

This position provides leadership to laboratory staff while ensuring efficient operations, regulatory compliance, and support of company quality objectives.

ESSENTIAL DUTIES AND RESPONSIBILITIES In coordination with the Quality Assurance Manager; interview, train and supervise personnel required to support the production of consumables in the laboratory and personnel required to support the validation of instruments.In coordination with the HR Manager; Coach, lead, and develop personnel to ensure organizational goals and objectives are met.

Carry out supervisory responsibilities in accordance with ATIs policies.

Responsibilities may include: ongoing/annual training, performance evaluations, addressing/resolving complaints/problems.

Ensure compliance with both federal, state and local laws, guidelines and best practices including those related to safety and health.Oversee Laboratory Technicians and Validators, and/or assists the Engineering and QC personnel when laboratory skills are needed to prepare reagents, or perform tests that advance the design, validation and/or production of a device.Oversee or perform CAP and other proficiency testing surveys.Assists with customer training and troubleshooting; answer customers questions about programming applications on ChemWell or other company products.Schedule and expedite production activities for orders placed, giving consideration to making the components, planning the timeline of the orders, and coordinating the products and materials needed for the orders.Oversees or prepares and logs the preparation of reagents used in the laboratory including QC dyes for in house use and dyes and reagents used in products that will be sold.Coordinate with the purchasing department to maintain inventory of materials to satisfy customer orders.Control and inspect expiration dates of inventory to control losses.Provide input, draft instructions for manufacturing/testing and product use (i.e.

Owners Manual, Customer Instructions and/or applicable training documents).Assist and/or perform activities required to produce regulatory documents.

e.g., FDA 510(k) submissions.Assist as needed in Safety, FDA, ISO and internal quality audits.Assures timely and accurate calibration and monitoring of measuring equipment.Perform activities to fulfill report requirements and record retention as established by ATI records retention policy.Analyze and suggest selected purchased equipment and monitor maintenance and service agreements.

Example: DI water system.Maintains the lab and its equipment in good working order, clean and organized.Ensure the laboratory, and all staff performing work in both labs, follows lab safety, biohazard safety practices and any other applicable regulatory requirement(s).

Provide ongoing/annual training to ap...