Scientist II, QC Microbiology
Company: Renaissance LLC
Location: Lakewood
Posted on: March 20, 2023
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Job Description:
Renaissance LLC
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.
Overview
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
laboratory.
Responsibilities
--- Follows current GMP requirements and complies with company
safety and controlled substance handling policies.
--- Performs sterility testing as per compendial requirements in an
isolator setting
--- 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
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.
--- 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.
--- 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.
Qualifications
Bachelor's degree in biology, health science or microbiology.
2-5 years' experience in cGMP micro expertise.
PI208215877
Keywords: Renaissance LLC, Lakewood , Scientist II, QC Microbiology, Other , Lakewood, New Jersey
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