Quality Control Technician, Microbiology

CRISPR Therapeutics•Framingham, MA

23h•Onsite

About The Position

The QC Microbiology team is looking for an engaged, self-driven individual interested in performing microbiology testing to support production activities of the cell therapy products located in Framingham, MA. As an QC Environmental Monitoring Technician, you will support routine environmental monitoring of air, surface, and gas utilities for manufacturing of in process and final product drug lots.

Requirements

Associate Degree/Certificate with 1-3+ years relevant GMP experience or BS in Biology or related discipline, with 0-2+ years of relevant GMP experience preferred
Ability to walk, bend, and crouch consistently throughout the shift.
Ability to lift sampling equipment weight up to twenty pounds.
Ability to wear full gown for up to 50-75% of the shift, this may be for up to 6 hours.

Nice To Haves

Experience with electronic GMP Quality Systems (ex. LIMS Labvantage and ComplianceWire)
Experience with collecting environmental monitoring samples.
Experience incubating and analyzing environmental monitoring samples.

Responsibilities

Collect and process environmental monitoring samples of air, surface, personnel gowning, and gas systems samples according to established schedules or as requested.
Ability to perform repetitive tasks while maintaining a high attention to detail.
Incubate and analyze environmental monitoring and process gas samples while ensuring activities occur in an efficient and cGMP compliant manner.
Participate in executing method validations and/or classified areas qualifications.
Maintain accurate sampling and testing records and adhere to cGMP/GDP expectations.
Review data, procedures, microbiological methods, protocols, reports, deviations, and other quality records.
Perform setup, maintenance, and cleaning of Environmental Monitoring instrumentation/ equipment, including the use of 70% Isopropyl Alcohol and Spor-Klenz.
Assist in everyday organization of the EM laboratory including safety, cleaning, maintenance, and ordering of supplies.