Environmental Monitoring Associate, Quality Control
Company: The Steely Group
Location: Cambridge
Posted on: March 20, 2023
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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:
Cambridge, MA
Cambridge, MA
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Keywords: The Steely Group, Cambridge , Environmental Monitoring Associate, Quality Control, Other , Cambridge, Massachusetts
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