Chemist

3 days ago

North Brunswick, United States Infinity Laboratories Full time
Job DescriptionJob Description

Chemist

Must Have:

  • Bachelor’s degree (B.S/B.A.) or higher in chemistry or another science-related field.
  • 5 years of experience in Analytical Method Development and Quality Control.

Summary:

Candidates in this position will focus heavily on utilizing analytical instrumentation to perform the testing of process validation samples, raw materials, finished products, stability studies, and developmental samples in a regulated laboratory environment in support of the timely disposition of manufactured products.

Essential Duties/Responsibilities

  • Utilize analytical instrumentation to perform routine release tests of raw materials and finished products to perform quantitative and qualitative analyses, including but not limited to:
    • HPLC (High-Performance Liquid Chromatography)
    • Gas Chromatography
    • Karl Fisher
    • Viscometer
    • Specific Gravity
    • Dissolution
    • Spectroscopy
    • pH.
  • Working hands-on with chromatographic integration and with Empower software.
  • Performing method validation and verification for new testing methods in the laboratory.
  • Evaluate test results and decide the acceptability of the samples based on the test results.
  • Reviewing and releasing of the raw data, documentation, and results for certificate of analysis.
  • Write draft technical documents like specifications, analytical methods, method verification protocols and reports, method transfer documents, investigation reports, etc.
  • Maintaining meticulous and precise records of all testing procedures, results, and any deviations from anticipated outcomes.
  • Knowledge of current GMP guidance, applicable USFDA and ICH guidelines, and regulatory requirements (such as USP/ICH requirements).
  • Ability to make observations with instruments and analysis techniques.
  • Ability to carry out necessary computations and to draw and interpret graphs.
  • Knowledge of basic to advanced level of computer skills.

Education:

  • Bachelor’s degree (B.S/B.A.) or higher in chemistry or another science-related field.

Experience:

  • 5 years of experience in analytical method development and Quality Control
  • Ability to maintain a safe, clean, and orderly lab environment.
  • Knowledge and experience of compliance requirements and cGMP
  • Experience keeping precise records.

Capabilities:

  • Ability to work independently in the laboratory with minimal supervision.
  • Proficiency in computers, databases, word processing, and spreadsheets required.
  • Excellent oral and written communication.
  • Troubleshooting and investigational skills.
  • Highly organized and able to manage multiple tasks in a fast-paced and growing environment.
  • Displays sound judgment, and has good communication, Implementation, and follow-up skills.
  • Able to achieve success with the BG&DS
  • Is comfortable with the goals, values, and philosophy of Infinity Laboratories

Infinity Laboratories is an Equal Opportunity Employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

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