Environmental Monitoring Technician

Responsibilities

• 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: Combination of 1st and 2nd shift, 5-week rotating schedule repeating the following schedule:
  • Week 1: Mon-Th 0600-1430
  • Week 2: Sat 1700-2100, Sun-Wed 1200-2130
  • Week 3: Sun 0400-1230, Mon-Thur 0500-1330
  • Weeks 4-5: Mon-Fri 0700-1530

Requirements

• Ensure a safe and quality working environment through training, awareness, and compliance with Safety/Quality guidelines and SOP’s.
• 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.
• 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.

Qualifications

• Associate degree or completion of college-level life science courses required.
• Relevant experience preferred.
• Good interpersonal, hands on, analytical, 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.