Environmental Monitoring Specialist

5 days ago


Bedford, Massachusetts, United States Tandym Group Full time

The Tandym Group is a leader in the pharmaceutical industry, seeking an experienced Environmental Monitoring Specialist to join their team. The estimated annual salary for this position in Bedford, Massachusetts is $65,000-$85,000.

Job Overview

As an Environmental Monitoring Specialist, you will be responsible for performing environmental monitoring tasks at a gene therapy manufacturing facility. This involves sampling room and personnel EM, water for injection (WFI), clean steam, and compressed gases. You will also be required to perform microbial enumeration, LIMS data entry, sample preparation, and assist with technical issues.

Responsibilities:
  • Perform environmental monitoring (EM) tasks following specified instructions and techniques from Standard Operating Procedures (SOP), Training Material, and other GMP documents.
  • Incubate and enumerate microbial growth on EM plates.
  • Ensure all tasks are completed in a GMP compliant and safe manner.
  • Document all tasks within LIMS or standard laboratory paper documentation utilizing GDP principles.
  • Entry of information into logbooks as applicable for tasks per SOP.
  • Partner and communicate with operations, manufacturing, facilities, and other site departments as required for support of operations and GMP processes.
  • Actively participate in daily and weekly laboratory meetings.
  • Accurately complete task management tools and handover communications.
  • Perform general lab tasks including cleaning and equipment preparation.
  • Maintain training for all required tasks.
  • May assist in laboratory investigations with limited scope.
Qualifications
  • Bachelor's degree with 0-2 years' experience, associate degree with 2+ years' experience, or High School Diploma [or Equivalent (GED)] with 4+ years' experience.
  • Previous environmental monitoring experience.
  • Good oral, written, and interpersonal communication skills.
  • Basic math skills and computer skills such as data entry, along with a high level of attention to detail.
  • A demonstrated ability to organize time independently, be able to perform several tasks concurrently (ability to multi-task) and be able to meet objectives in a team-oriented environment.
  • Must maintain aseptic qualifications.
Physical Demands/Work Environment/Safety Considerations
  • Stand for extended periods of time with periodic stooping / bending / kneeling.
  • Able to lift, push, pull up to 50lbs.
  • Climb ladders and stairs of various heights.
  • Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body.


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