Renaissance
Location
Lakewood, NJ | United States
Job description
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 specifications.
• Maintain training logs to comply with current SOP requirements.
• 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 required.
3-5 years’ experience in cGMP analytical laboratory.
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