Quality Control Chemist

Santa Rosa, CA
Full-Time
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Summary/Purpose of Job

To perform Quality Control operations and to evaluate the quality of products through testing, and to support Quality Unit activities.

Essential Duties/Responsibilities

QC tasks:

  • Performing QC testing and/or release of cGMP materials (for example, advanced Intermediates and Active Pharmaceutical Ingredients) in accordance to cGMP requirements
  • Maintenance of Quality Control related documentation (QC SOPs and methods, test methods, analytical validation and/or qualification, reference standard qualification, and stability studies)
  • Ensuring that the QC laboratory is functional and equipped with equipment/utensils and test materials as needed
  • Qualification and calibration of analytical equipment and/or approval of calibration results
  • Execution and/or approval of qualification, validation and stability protocols and/or reports

Other:

  • Helping create a positive work environment
  • Other reasonable duties may be assigned as necessary

Qualification Requirements

  • Minimum of a bachelor’s degree in chemistry with at least 5-year experience in analytical testing in cGMP environment; advanced degree preferred
  • cGMP training including FDA and ICH guidelines
  • High level of proficiency in using Agilent chromatographic instruments
  • Ability to write and/or type large volumes of information with excellent attention to detail

Physical Demands/Work Environment

  • Ability to safely handle hazardous materials
  • Ability to move 50 pounds
  • Ability to bend to reach floor level
  • Ability to wear respirator

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