Perform routine environmental monitoring of aseptic processing and controlled area cleanroom environments used for pharmaceutical manufacturing. Perform assigned quality control or quality assurance activities in compliance with applicable SOP's and cGMPs.

Schedule: Monday - Friday 12am - 8:30 am

• Ensure a safe and quality working environment through training, awareness, and compliance with Safety/Quality 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 of the department, premises, and equipment.
• Ensure that all necessary testing is carried out by required due dates. Perform all assigned tasks confidently and consistently.
• 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).
• Ensure assigned tasks are performed confidently and consistently.
• Ensure the use of proper aseptic technique during testing of controlled environments and utility systems.
• Perform all work in compliance with site quality, site safety and radiation protection guidelines.
• Collaborate with team members to ensure quality tasks is performed in a timely manner.
• Must demonstrate flexibility in adjusting to changing priorities and schedules.
• Attend mandatory training as required by site regulatory requirements and management.
• Assist with investigations.
• Perform other general duties associated with the position as required by supervision.

• Associate degree or completion of college-level life science courses required. Work experience is considered in lieu of degree.
• 1or more years of relevant experience required.
• Good interpersonal skills, hands on, analytical, and problem solving and decision-making skills.
• Excellent writing and verbal communications skills.
• Good computer skills, including utilizing personal computers and data entry programs.
• Ability to work independently and with others to accomplish goals and priorities.
• Flexibility and teamwork skills, high level of energy and regular, consistent attendance.

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.