Environmental Monitoring Technician

3 days ago

Durham, United States Medasource Full time

Position: Environmental Monitoring Technician (RTP EM Tech)

Duration: 6-12 Month contract

Location: Durham, NC - ONSITE

Schedule: 12 hour day or night shift, 2-2-3 (2 days on, 2 days off, 3 days on, etc.). Contractors will work 36 hours one week, 48 the next, etc.

Start: ASAP


Summary:

The QC Environmental Monitoring Technician will perform routine and investigational environmental monitoring of classified manufacturing, filling, and support areas. Support daily EM laboratory operations.


Responsibilities:

  • 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:

  • 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 Qualifications:

  • 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.
  • 12 hour shifts on 2-2-3 schedule, days or nights

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