Quality Assurance Specialist II

4 weeks ago


Richmond, California, United States Yoh Full time
Quality Assurance Specialist II

Yoh is seeking a Quality Assurance Specialist II to support manufacturing activities, including investigations of product non-conformance and deviations, blocking of non-conforming material, batch record and CoA review and release. The ideal candidate will have a strong understanding of Quality principles and be able to guide manufacturing partners in the correct path for cause investigation and issue resolution.

Responsibilities:
  • Support batch release for LSG mfg sites
  • Support Veeva integration for NorCal (Change Control, Nonconformance Management)
  • Verification of Change Control activities
  • Rapid containment of product quality issues
  • Audit preparedness
Requirements:
  • Understanding of GMP/ISO regulations (ISO 13485, MDSAP, FDA 820/210/211)
  • Working knowledge of device/drug/biotech manufacturing processes
  • Detail-oriented, excellent organization and project management skills
  • Decision making, time management, organization, communication, leadership, and computer skills
What We Offer:
  • Medical, Dental & Vision Benefits
  • 401K Retirement Saving Plan
  • Life & Disability Insurance
  • Direct Deposit & weekly ePayroll
  • Employee Discount Programs
  • Referral Bonus Programs


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