Lead Environmental Monitoring Technician

Summary of Position

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.

Essential Functions

• Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines and SOP’s.
• Ensure the maintenance and cleanliness of their department, premises and equipment.
• Act as leader in area of responsibility & monitor FDA, NRC, ALARA, and OSHA requirements.
• 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.
• Assist in the training of less experienced technicians & monitor schedules.
• 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.
• 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.

Requirements

• Bachelor Degree in Biology, Chemistry or related Science field
• 6 to 8 years of general quality / quality control / production experience in a cGMP facility required.
• 2 to 3 years of pharmaceutical laboratory experience preferred
• 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 a plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities also include the ability to lift up to 70 pounds, walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation.
• Must be willing to wear a variety of personal protective equipment.
• Willingness to work in a team-based environment.
• Close attention to detail required.
• May be required to sit or stand for long periods of time while performing duties.
• Must be able to work outside of regular work hours.
• Must possess good hand-eye coordination.