Quality Control Microbiologist
Company: Integrated Resources, Inc ( IRI )
Location: Cambridge
Posted on: June 19, 2022
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Job Description:
Title: Quality Control Analyst ILocation: Cambridge, MADuration:
12 months+(possible extension)Job description: Primary
responsibilities- (80%) - Environmental monitoring of clean rooms
(Air viable sampling, surface sampling and Non-viable Particulates
sampling) - Plate reading - Data entry/verification - RODI Sampling
- Sample shipment Secondary responsibilities- (20%) - Growth
promotion testing - Gowning qualification - EM investigations -
Assist in microbial testing as needed (Sterility, Endotoxin and
Mycoplasma) - Other micro support as needed OBJECTIVES: --- The
Analyst, Cell Therapies QC Microbiology is responsible for the
performance of microbiological related activities at the Cell
Therapies Manufacturing Facility in Cambridge. --- This position is
responsible to assist in all microbiological related activities
needed in the in-house GMP cell therapies production of
investigational new drugs from development, transfer,
(re-)qualification, (re-)validation to routine performance
activities. ACCOUNTABILITIES: Primary responsibilities: --- Perform
environmental monitoring (viable particle monitoring -air, settle
plates, contact plates as well as non-viable particulate
monitoring) of the Cell Therapies Manufacturing Facility in
Cambridge. --- Perform plate reading and Data entry/verification of
the test results. --- Perform RODI sampling. --- Responsible for
shipping and tracking samples and test results. --- Participate in
environmental monitoring performance (re-)qualifications and
aseptic process (re-)validations. --- Maintain data integrity and
ensure compliance with company SOPs, specifications and cGMP
regulations. --- Keep the Microbiology lab clean, safe and tidy all
the time. Secondary responsibilities: --- Perform gowning
qualifications for personnel needing access to the internal GMP
facility. --- Perform growth promotion tests. --- Assist in release
testing (Sterility, Endotoxin and Mycoplasma) related to
microbiology as needed to support the manufacturing of
investigational new cell therapy drug products manufactured in the
internal GMP facility in Cambridge. --- Assist in the EM
investigations per SOP. --- Other Micro support as needed.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: --- Bachelor's
Degree in Microbiology or another relevant field --- Minimum of 1-2
years' experience in the bio/pharmaceutical industry --- Minimum of
1-2 years' experience in GMP QC Microbiology laboratory ---
Experience in performing environmental monitoring in GMP cleanrooms
(Grade A-C) --- Experience in gowning qualification and aseptic
techniques --- Microbiology knowledge and practical experience of
microbiology testing --- Experience using MODA is a plus ---
Excellent organizational, communication, and interpersonal skills
--- Ability to adapt to changing priorities
Keywords: Integrated Resources, Inc ( IRI ), Cambridge , Quality Control Microbiologist, Other , Cambridge, Massachusetts
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