QC Microbiologist I, Environmental Monitoring
Location: Bedford
Posted on: June 23, 2025
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Job Description:
The QC Microbiologist I, Environmental Monitoring will learn,
understand, and perform routine entry level sampling of cleanrooms
and utilities according to written procedures under cGMP
conditions; as well as tasks involved with clerical and logistical
laboratory tasks. Specific Responsibilities: • Environmental
Monitoring of ISO-5, ISO-7, and ISO-8 cleanrooms (contacts, viable
airs, and total particulate sampling) in accordance with approved
methods • Perform gowning qualification of personnel • Utility
sampling of RODI/WFI water systems (collect Bioburden and Endotoxin
samples for testing) in accordance with approved methods • Train
personnel on environmental monitoring • Prepare and host
environmental monitoring meetings • Document all results in
accordance with SOP • Report procedural deviations and
nonconformances to management • Write and review investigations
(Environment Control Notification, NCR, OOS, Planned Deviation) •
Preparing samples for outside vendor testing • Receiving and
approval stickering of incoming microbiological media and reagents
• Perform data entry, filing, and scanning of completed documents •
Sterilization and cleaning of laboratory equipment • Sampling of
incoming raw materials as needed (i.e. Sodium Hyaluronic Acid
Powder) • Monitor room pressure readings in cleanrooms daily. •
Participate in other projects as assigned Job Complexity: The
position normally works on assignments routine in nature and
receives detailed instructions on all work. Responsible for
supporting QC Laboratory working environment Experience, Knowledge,
and Skills Required: • Associates or Bachelors Degree preferred or
equivalent experience. • 1 – 2 years previous experience in a GMP
laboratory desired; internship experience considered • ISO-5 (also
known as Grade A or Class 100) Gowning experience • Ability to work
flexible hours to complete work activities • Self-motivated with
good time management and organizational skills • Good communication
and writing skills
Keywords: , Brookline , QC Microbiologist I, Environmental Monitoring, Science, Research & Development , Bedford, Massachusetts
