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OPEN POSITIONS

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Nutraceutical company is seeking a Quality Control/ Quality Assurance Supervisor for their manufacturing facility in the Riverside, California. The successful candidate will play a key role in implementing quality of dietary supplements in a manufacturing environment.

Job Requirement

  • Create and establish a scientific approach to the company quality system
  • Ensure all GMP, GLP, GCP operations are in compliance
  • Establish training and audit programs and create and review SOPs
  • Conduct investigations, specifications, methods, validation reports, cleaning verification reports, analytical reports and master manufacturing records
  • Develop strategies for and introduce quality policies to set up system and documentations
  • Manage the manufacturing team in terms of product quality and provide cGMP training
  • Prepare and submit submissions and ensure compliance with all regulatory requirements pertaining to product approval
  • Provide periodic update on regulatory requirement changes, which affect individual product specification or quality systems
  • Foster collaborative, efficient, and effective working relations with regulatory authorities such as FDA
  • Manage external contract laboratory for contract testing
  • Responsible for the release or rejection of cGMP materials and utilize QA staff to manage the timeline and assure on time delivery of approved materials
  • Act as company’s representative during regulatory agencies and customer inspections

Qualifications

  • Minimum of 5 years of relevant quality compliance experience with dietary supplement and OTC
  • Thorough understanding of GMP
  • Experienced in testing and cGMP products documentation
  • Experience in effectively managing FDA inspections and customer audits

Job Type: Full-time

Salary:  Based on experience.

Interested? Please email your resume to: careers@kelkerpharma.com