Environmental Monitoring Associate, Quality Control

Company: The Steely Group
Location: Cambridge
Posted on: March 20, 2023

Job Description:

Environmental Monitoring Associate, Quality Control Bedford , MA 01730 Job Description Provides support and environmental monitoring (EM) for the GMP gene therapy manufacturing facility (GTMF). Sampling includes room and personnel EM, water for injection (WFI), clean steam, and compressed gases. Gas testing is performed at the time of sampling at each point of use. Performs microbial enumeration of incubated plates and LIMS data entry, as well as assist in preparing samples for transport.

May assist with resolving technical issues, as well as maintenance and cleaning of environmental monitoring equipment and incubators. May review existing procedures and provide technical expertise to improve SOPs and Work Instructions. Participates in periodic data review and trending of EM results with assistance from area management. May be required to work periodically during nights/weekends as production schedule dictates (flex hours). May be required to assist with deviations, investigations and CAPA actions.

This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.

Responsibilities:

• Perform environmental monitoring (EM) tasks for the aseptic environment, other controlled areas, and plant utility systems 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.Requirements / Qualifications:
  • 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. Related Jobs:
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Keywords: The Steely Group, Cambridge , Environmental Monitoring Associate, Quality Control, Other , Cambridge, Massachusetts