Quality Assurance Specialist
5 days ago
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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