Scientist II, Quality Control Analytical - 2nd Shift
Company: Renaissance Services
Posted on: September 23, 2022
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 identifies basic technical problems,
atypical results or methodology malfunctions and assists in the
investigation to correct them. This role provides technical support
for routine testing activities and conducts physical and chemical
analyses of samples, products and materials. This role ensures
notebooks and reports are in compliance with regulatory guidelines,
completes projects within time limits and budgetary constraints,
performing mathematical calculations, interprets results, records
observations and responds to and assists in audits and
investigations. The role is primarily responsible for technical
transfer and validation of methods to support quality control
testing of products and materials. The incumbent will provide
guidance to junior staff members with respect to training.
--- Accurately generate data using validated test methods and SOPs
in cGMP environment.
--- Demonstrate technical competence in the use of wet chemical
techniques and instrumentation pertinent to the job including
Infrared Spectroscopy, Ultra Violet/Visible Spectroscopy, Gas
Chromatography, High Pressure Liquid Chromatography, Ultra High
Pressure Liquid Chromatography, Atomic Absorption Spectroscopy,
Dissolution apparatus, Compendial testing (USP, EP, JP).
--- 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.
--- Works with vendors to obtain documents for instrument
maintenance or upkeep. May assist with evaluating vendor,
compendial and third-party test methods to determine qualification
of performing the method in-house.
--- Understand and execute protocols and provide information to
qualify and draft in-house test standards and methods.
--- Revise SOPs and methods as needed. May be asked to draft
protocols, SOPs or methods.
--- Performs instrument and method related troubleshooting.
--- Performs investigative testing as needed.
--- Trains other scientists in various methodologies.
--- Responsible for analyzing data, maintaining accurate and
detailed written records and notebooks and thorough review of lab
notebooks to ensure compliance to test methods and
--- Maintain training logs to comply with current SOP
--- Assists in revising SOPs or methods.
--- Ability to work in a team environment.
--- Ensure safety regulations are adhered to in the laboratory.
--- Must comply with all company policies.
--- Flexibility in schedule is required.
--- Other duties, as assigned.
Bachelor of Science Degree in Chemistry, Biology or related science
2-5 years' experience in cGMP analytical laboratory.
Keywords: Renaissance Services, Lakewood , Scientist II, Quality Control Analytical - 2nd Shift, Other , Lakewood, New Jersey
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