Job description
Job Title: Environmental Monitoring Associate, Quality Control- Contract
Site Location: Bedford, MA
Experience level: Entry level, must have some GMP or clean room experience
Contract Length: 12 months
Pay Rate: $38 an hour
Position Summary:
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. Required to perform 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. Responsible for 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.
Work Model:
Core Lab & Ops: This role requires all work to be conducted on-site.
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.
Requirements:
- Bachelor’s degree with no experience, associate degree with 2+ years’ experience, or High School Diploma [or Equivalent (GED)] with 4+ years’ experience.
- Good oral, written, and interpersonal communication skills.