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Scientist I, Quality Control Analytical

Company: Renaissance LLC
Location: Lakewood
Posted on: October 14, 2020

Job Description:

Renaissance LLCAll 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 Scientist I, Quality Control Analytical will provide technical support for routine testing activities and conduct physical and chemical analysis of samples, products and materials. Primarily responsible for technical transfer and validation of methods to support quality control testing of products and materials. Identify basic technical problems, atypical test results or methodology malfunctions and assist in the investigation to correct them. Other important duties include ensuring notebooks and reports are in compliance with regulatory guidelines, completing projects within time limits and budgetary constraints, performing mathematical calculations, interpreting results, recording observations and responding to and assisting in audits and investigations. Participate in departmental training and provide guidance to junior staff members.

Responsibilities

  • Accurately generate data using validated test methods and SOPs in a cGMP environment.
  • Demonstrate technical competence in the use of wet chemical techniques and instrumentation pertinent to the job including:
    • IR Infra-Red Spectroscopy
    • UV/Vis Ultra Violet/Visible Spectroscopy
    • GC Gas Chromatography
    • HPLC High Pressure Liquid Chromatography
    • UPLC Ultra High Pressure Liquid Chromatography
    • AA Atomic Absorption Spectroscopy
    • Dissolution apparatus
    • Compendial testing (USP EP, FCC) - ex. Monograph assay, limits tests, chemical and physical tests
      • Responsible for analyzing data, maintaining accurate and detailed written records and notebooks and thoroughly reviewing lab notebooks ensuring compliance to test methods and specifications.
      • Ability to work in a team environment.
      • Train other Scientists and Lab Technicians in various methodologies.
      • Maintain training logs to comply with current SOP requirements.
        Ensuring safety regulations are adhered to in the laboratory.

        Qualifications

        Bachelor's Degree (BA or BS) in Chemistry, Biology or related science required with a minimum of 5 years of relevant experience in the pharmaceutical industry; or equivalent combination of education and experience.

Keywords: Renaissance LLC, Lakewood , Scientist I, Quality Control Analytical, Other , Lakewood, New Jersey

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