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Quality Specialist - Risk Management
Santa Cruz Nutritionals - Santa Cruz, CA




Santa Cruz Nutritionals, a leading manufacturer of gummy vitamins and supplements is seeking a Quality Specialist, Risk Management / Annual Product Review to develop and maintain the Quality Risk Management program.

Job Description:

  • Develop and maintain the Quality Risk Management program.
  • Provide site support in quality risk management with training on risk principles and tools, risk assessment facilitation, management of quality and site significant risks.

Essential Duties:

  • Develop a quality risk management program and associated quality preventative controls per regulatory requirements.
  • Perform risk based gap analysis of existing food safety procedures and programs vs. regulatory, certificatory, and customer requirements.
  • Represent quality risk management on cross functional teams
  • Assist with integration of quality risk management process into site operations
  • Create quality risk management principles and tools used for risk assessing
  • Develop and maintain metrics or key performance indicators for determination of risk mitigation effectiveness
  • Draft new and review and edit existing SOPs for accuracy and compliance with internal procedure/policy and applicable regulations.
  • Perform Batch Investigations to determine root cause for OOS Batch Results, Customer Complaints or Deviations.
  • Provide statistical support of risk assessments
  • Perform annual product reviews (as required by customer)
  • Provide statistical support to QC laboratory and other departments as needed.
  • Assist with Internal Audits and Customer Audits as needed.
  • Assist with projects as assigned by Management.

Minimum Requirements:

  • Significant familiarity with 21CFR110 and 21CFR111
  • Knowledge of FSMA requirements (21CFR117) ó HARPC, FSVP, Food Defense
  • Ability to perform and defend statistical analyses of risk
  • Familiar with Risk Management practices
  • Strong verbal and written communication skills and interpersonal skills
  • Proficiency with Microsoft Office
  • 2+ years experience in a Quality Assurance cGMP environment

About the Company

Santa Cruz Nutritionals is a leading manufacturer of gummy vitamins, supplements, and organic fruit snacks. SCN operates in a fast growing industry and has consistently grown at +20% a year over the past 8 years. Today, the majority of SCNís business is through contract manufacturing for leading supplement brands, along with private label manufacturing for many of the largest retailers in NA. SCN sells over 350 unique formulas of gummy products and launched over 50 new products in the past 12 months alone.

SCN has an innovative pipeline of growth opportunities staged for the next 5 years that is expected to continue to provide double digit growth rates and will enable SCN to enter into new categories we arenít competing in today. SCN is looking for sharp and talented individuals who enjoy being part of a fast paced, growth organization.

Santa Cruz Nutritionals is an Equal Opportunity Employer

Job Type: Full-time

Required education:

  • Bachelor's

Required experience:

  • 21CFR110 and 21CFR111: 2 years
  • FSMA requirements (21CFR117) Ė HARPC, FSVP, Food Defense: 2 years
  • Quality Assurance: 2 years
  • Risk Management: 2 years


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