Scientist II, QC Microbiology
Company: Renaissance LLC
Posted on: January 19, 2023
All qualified applicants will receive consideration for employment
without regard to race, color, sex, sexual orientation, gender
identity, religion, national origin, disability, veteran status,
age, marital status, pregnancy, genetic information, or other
legally protected status.
The purpose of this role 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
--- Follows current GMP requirements and complies with company
safety and controlled substance handling policies.
--- Participates in repair and maintenance of lab equipment and lab
housekeeping (disinfection and cleaning).
--- 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
--- Performs environmental monitoring, as required; Evaluates,
records and reports data.
--- Performs quality control testing of media, reagents, and
--- Maintains adequate inventory of media and materials required
--- Initiates proper documentation upon discovery of deviations and
out of specification results, completes Trackwise write-up for
deviations and out of specification results.
--- 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
--- Performs micro identifications using manual testing and
--- Maintains lab stock cultures for evaluative testing and make
dilutions of stock cultures as required by procedure, protocol, or
--- Maintains intradepartmental communication to support company
--- Reviews laboratory logbooks to ensure compliance with good
--- 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
--- Interact with Operations staff to facilitate data and
documentation corrections. Interacts routinely with departments
such as Production, Quality Assurance and Regulatory Affairs.
--- Creates purchase orders as needed.
--- Flexibility in schedule is required.
Bachelor's degree in biology, health science or microbiology.
2-5 years' experience in cGMP micro expertise.
Keywords: Renaissance LLC, Lakewood , Scientist II, QC Microbiology, Other , Lakewood, New Jersey
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