Quality Assurance Specialist III

1 week ago

Irvine, California, United States Kelly Science, Engineering, Technology & Telecom Full time
Job Summary

Kelly Science, Engineering, Technology & Telecom is seeking an experienced Quality Control Chemist to join our team in Irvine, CA. As a member of our Quality Control Department, you will play a pivotal role in ensuring the quality and integrity of our pharmaceutical products through meticulous analytical testing and method development.

Key Responsibilities
  • Method Validation and Verification: Perform method validation, verification, transfer, and analytical testing for clinical submission materials, including raw materials, finished products, stabilities, and cleaning validation.
  • Instrumentation Maintenance: Maintain and troubleshoot analytical instrumentation.
  • Laboratory Investigations: Perform and document laboratory investigations, as necessary.
  • Data Review: Peer review data generated by other chemists and technicians.
  • Method Development: Develop, validate, and troubleshoot analytical methods.
  • Method Transfers: Conduct method transfers from other facilities and departments.
  • Procedure Authoring: Author standard operating procedures and analytical methods.
  • Equipment Calibration: Perform and/or assist with equipment calibrations and qualification.
  • Laboratory Training: Assist laboratory management with laboratory employee training.
  • Audit Preparation: Assist laboratory management in preparation for internal, customer, and agency audits.
Requirements
  • Education: Bachelor's degree in chemistry or related discipline.
  • Experience: 5+ years' experience in a chemistry laboratory, or equivalent combination of education and experience.
  • Instrumentation Experience: 5+ years' experience with analytical instrumentation, such as HPLC, GC, CE, ICP, FTIR, and dissolution apparatus required.
  • GLP/GMP Experience: 2+ years' experience in GLP or GMP (preferred) environment.
  • Communication Skills: Strong communication skills, both written and verbal.
  • Organizational Skills: Ability to organize, prioritize, and effectively perform concurrent tasks with minimal supervision.
  • Attention to Detail: Strong attention to detail.

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