QC Environmental Monitoring Technician

4 weeks ago

Durham, United States Medasource Full time

Position Title: Expert Process Technician – Environmental Monitoring

Location: Fully Onsite Research Triangle Park

Duration: 6-12 month contract

Start Date: ASAP


Position Description: Our client is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The QC Environmental Monitoring Technician will perform routine and investigational environmental monitoring of classified manufacturing, filling, and support areas. Support daily EM laboratory operations.


Key Objectives/Deliverables:

  • Support production operations by means of EM sampling of classified manufacturing, filling, and support areas and operations personnel.
  • Support daily EM laboratory operations and process/equipment qualification activities, as necessary.
  • Ensures compliance with current Good Manufacturing Practice (cGMP) and maintain constant inspection-readiness.
  • Ensures that data-integrity is maintained
  • Participate in process streamlining and continuous performance improvement.
  • Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
  • EM Technician requires gowning certification, and repeatedly aseptically gown daily.


Requirements (Education, Experience, Training):

  • High School Diploma or equivalent, Associates degree preferred.
  • Understanding of cGMP
  • Excellent written and oral communication skills and ability to collaborate and interact with a team.
  • Work in a dynamic and fast paced environment with potential to work shifts and weekends.
  • Must be able to lift 30 pounds and be able to pass, push, and pull to execute specific aspects of job duty.
  • Must be able to stand / walk for extended periods of time.


Preferred attributes but not required:

  • Environmental Monitoring experience preferred.
  • Manufacturing or production experience preferred.
  • Experience in Aseptic manufacturing or production, QC, QA, Technical Services, or Regulatory is desirable.
  • Technical writing and written communication skills are a plus.
  • Understanding of regulatory standards / requirements for EM.
  • Knowledge of / familiarity with Parenteral production environments and operations.
  • Strong computer skills, documentation skills, and attention to detail.
  • Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate and Site Goals.
  • Ability to focus on continuous improvement.
  • Previous experience with laboratory IT systems including LIMS, LES, and standalone COTS systems.
  • Understanding of compliance requirements and regulatory expectations for lab systems.


Additional Information:

  • Minimal travel required
  • Some allergens are present in the parenteral plant.
  • First and second shift work may be required.
  • You must be comfortable with the schedule that is open to change


This job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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