Quality Assurance Specialist

5 days ago


Hillsboro, United States Genentech Full time
Job Title: Quality Validation Engineer II/Senior

About the Role:

We are seeking a highly skilled Quality Validation Engineer II/Senior to join our team at Genentech. As a key member of our Hillsboro Technical Operations organization, you will play a critical role in ensuring the quality and reliability of our commercial portfolio and pipeline products.

Key Responsibilities:

  • Apply knowledge of qualification and validation principles, manufacturing processes, quality systems, engineering design fundamentals, health authority expectations, and industry standards to review and approve qualification and validation documents.
  • Perform quality oversight of equipment, facility, and utility systems, GMP computerized systems, drug product manufacturing processes, cleaning processes, sterilization processes, and analytical methods.
  • Develop new approaches to complex problems and lead others to solve the problem through coaching conversations.
  • Work independently within broad guidelines and policies, with guidance in only the most complex situations.
  • Serve as a best practices/quality resource on highly significant matters relating to policies, programs, capabilities, and long-range goals and objectives.
  • Lead sub-streams or participate in global/large cross-functional project teams to solve complex problems.

Requirements:

  • Bachelor's degree with 8 years of industry experience or Master's with 5+ years for a QEV II or 12 years of industry experience or Master's with 8 years for a Senior QEV.
  • Industry experience preferably in technical validation or quality validation.
  • In-depth specialist knowledge of own job discipline and broad knowledge of related disciplines in the field.
  • Recognized internally as an expert in own job discipline.

What We Offer:

  • Competitive salary range of $88,000 - $163,000 based on location and experience.
  • Discretionary annual bonus based on individual and company performance.
  • Relocation benefits available for this position.
  • Equal opportunity employer with a commitment to diversity and inclusion.


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