QC Chemist II Raw Materials Data Reviewer

Location: Buena, NJ

Job Summary:

Provide thorough, accurate, and timely review of registration batch release and stability data to support the product development/regulatory submission schedule.

Reporting Relationships:  Individual Contributor

Essential Responsibilities:

  • Perform detailed data review of registration batch release and stability sample data collected using wet chemistry, physical, and instrumental techniques including but not limited to TLC, HPLC, GC, viscosity, specific gravity, and particle size as directed by the lead chemist and area manager.
  • Create and implement a system recording and reporting group metrics including testing time, reporting time, review time, and release time.
  • Participate in DART response and ANDA submissions.
  • Participate in laboratory investigations.
  • Maintain and follow all laboratory systems, GMPS, safety and housekeeping requirements.
  • Prepare and review SOPs, as required.
  • Keep supervisor informed of all key quality findings and issues.
  • Assume other activities and responsibilities from time to time as directed.

Qualifications:

  • BS in Chemistry or related discipline, 2-5 years of pharmaceutical industry or laboratory experience.
  • Industry experience using HPLC.
  • Knowledge of cGMPs and good documentation practices.
  • Strong foundation in analytical chemistry and quantitative analysis.
  • Demonstrated ability to apply good laboratory techniques while maintaining the efficiencies required in Quality Control.
  • Observant.  Receptive to learning and applying new skills and techniques.
  • Collaborative working style.  Demonstrates professionalism, cooperation and willingness to support team members and company priorities.
  • Well-developed interpersonal skills.  Ability to get along with diverse personalities.
  • Good written and oral communication skills.
  • Demonstrated ability to work on multiple projects and meet timelines.

 Physical Demands/Factors:

  • Physical Demands
    • Mobile/Ambulatory
    • Ability to lift
    • Sight
  • Environmental
    • Inside and outside work
    • Move between buildings
    • Temperature variations
    • Sit and stand for long periods

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.

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