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Senior Quality Assurance Specialist

2 months ago

Sacramento, California, United States Hispanic Technology Executive Council Full time
Job Summary

The Senior Specialist, Quality Assurance executes quality programs, policies, and procedures in a particular area of specialty (such as recalls and customer complaints) in order to minimize risks and drive supply chain integrity.

Key Responsibilities
  • Ensures fulfillment of external reporting requirements related to area of specialty, such as submitting necessary materials for product recalls.
  • Executes internal programs to define Quality guidelines and track adherence to these guidelines.
  • Responds to significant quality issues and conducts root cause analyses, reports on relevant quality metrics and trends, and develops insights for internal stakeholders.
  • Supports the Change Control Program, by assessing Quality Assurance implications and impacts of operational and product changes, with a focus on specialty area.
  • Updates standard operating procedures in response to product changes and regulatory developments.
  • Prepares responses to regulatory queries, regulatory audits, and corporate audits and gathers necessary information from products and operations stakeholders.
  • Supports quality audits and inspections of distribution centers within the region.
  • Provides guidance to junior level Specialists on complex issues, assists with onboarding trainings, and frequently reviews the work of Specialists prior to delivery to a Manager.
Requirements
  • 2-4 years of experience, preferred
  • Bachelor's degree in related field, or equivalent work experience, preferred
  • cGMP experience highly preferred
  • Analytical equipment knowledge such as GC and HPLC
What We Offer
  • Competitive salary range: $75,600 - $108,000
  • Comprehensive benefits package, including medical, dental, and vision coverage
  • Paid time off plan
  • Health savings account (HSA)
  • 401k savings plan
  • Access to wages before pay day with myFlexPay
  • Flexible spending accounts (FSAs)
  • Short- and long-term disability coverage
  • Work-Life resources
  • Paid parental leave
  • Healthy lifestyle programs