Scientist II - QC Microbiology 2nd shift
Company: Gables Search Group
Posted on: September 23, 2022
The purpose of the Scientist II, QC Microbiology is to test and
report cGMP test results for the Quality Control Microbiology
Laboratory. This role also provides training and support for less
experienced members of the laboratory. Responsibilities: Initiates,
documents and performs microbiological analysis on received test
samples (including raw materials, bulk, final product, stability,
water) as per USP, in-house or customer methods. Evaluates, records
and reports data under minimal supervision. Performs environmental
monitoring, as required; Evaluates, records and reports data.
Performs quality control testing of media, reagents, and
identification materials. Maintains adequate inventory of media and
materials required for testing. Initiates proper documentation upon
discovery of deviations and out of specification results, completes
Trackwise write-up for deviations and out of specification results.
Participates in repair and maintenance of lab equipment and lab
housekeeping (disinfection and cleaning). Performs special projects
as assigned including testing, compiling and trending of data and
report generation. Performs data entry for tracking and generates
trend analysis reports for EM program, etc. Revises SOPs, forms,
protocols and other controlled documents. Performs micro
identifications using manual testing and automated systems.
Maintains lab stock cultures for evaluative testing and make
dilutions of stock cultures as required by procedure, protocol, or
USP requirements. Maintains intradepartmental communication to
support company goals. Reviews laboratory logbooks to ensure
compliance with good documentation practices. Releases
manufacturing areas after recovery using the ASCN in Trackwise.
Writes Trackwise notifications and deviations and completes CAPAs.
Creates and completes Trackwise change controls. Writes and revises
SOPs, forms, risk assessments and other controlled documents.
Flexibility in schedule is required. Requirements: Bachelors degree
in biology, health science or microbiology. 2-5 years experience in
cGMP micro expertise.
Keywords: Gables Search Group, Brick , Scientist II - QC Microbiology 2nd shift, Other , Jackson, New Jersey
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