Lead Environmental Monitoring Technician

The Lead Environmental Monitoring Technician will direct coordination of technicians in their area of responsibility while performing assigned quality control or quality assurance activities in order to comply with applicable SOPs and cGMPs.

Schedule: Monday - Friday 6:30am - 3:00pm

• Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines and SOP's.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Ensure the maintenance and cleanliness of their department, premises and equipment.
• Act as leader in area of responsibility & monitor compliance requirements (i.e. FDA, HC, TGA, NRC, OSHA, etc.).
• Ensure that all necessary testing is carried out by required due dates. Perform all assigned task confidently and consistently.
• Maintain qualification status on all applicable SOP's, OJT's, and related tasks in your area and be able perform these responsibilities as required by business needs.
• Perform monitoring using lab equipment and techniques (SAS, SMA, Met One particle counter, viable airborne monitoring (active and passive), total airborne particulate sampling, viable surface monitoring, personnel monitoring, and membrane filtration of water samples).
• Assist in the training of less experienced technicians & monitor schedules.
• Ensure the use of proper aseptic technique during testing of controlled environments and utility systems.
• Attend mandatory training as required by site regulatory requirements and management.
• Assist with investigations.
• Ensure strict adherence to quality and safety procedures in the testing of sterile, injectable pharmaceuticals in accordance with OSHA and cGMP guidelines.
• Ensure proper documentation of all processes and procedures in accordance with cGMP guidelines.
• Investigation of laboratory or quality deviations and out of specifications, product failures, and customer complaints.
• Ensure and document necessary training.
• Ensure proper maintenance of all equipment and instruments in your area.
• Provide a team environment in which Analysts are empowered to make appropriate decisions and encouraged to participate in projects.
• Management of inventory and ensuring all laboratory supplies are appropriately stocked.
• Support plant / team changes and initiatives.
• Participate in continuous improvement efforts, including cost reductions and lean manufacturing initiatives.
• Support and participate in plant Quality initiatives.
• Complete daily paperwork.
• Assist supervision with planning, training, and scheduling personnel. Provide back- up assistance in the absence of the supervisor.
• Provide personnel performance related input to supervisor.
• Serve as source of technical knowledge when required.
• Act in manner that provides leadership, incentive, and cooperation for subordinates, peers, and supervisors.
• Complete job responsibilities in a manner that fosters and builds cooperation and team work within work groups.
• Assist with laboratory investigations, root cause analysis, and implementation of corrective and preventative actions.
• Perform other general duties associated with the position as required by supervision.

• Bachelor Degree in Biology, Chemistry or related Science field required. Work experience is considered in lieu of degree.
• 3 or more years of relevant experience required.
• Experience with personal computers and data acquisition
• Good analytical and problem-solving skills
• Good interpersonal and communication skills.
• Strong leadership skills. Ability to multi-task in a high-stress environment.
• Self-directed and self-motivated.
• Working knowledge of cGMP guidelines.
• Understanding of lean manufacturing concepts.
• Detail-oriented.
• Adaptability to quickly changing situations.
• Able to efficiently use computers, reference manuals, & other equipment as needed.
• Good interpersonal and communication skills.

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.