Quality Assurance Specialist/Senior QA Specialist, Investigations

Genentech • Hillsboro, OR

407d • $75,000 - $139,400 • Onsite

About The Position

The QA Specialist/Senior QA Specialist at Hillsboro Technical Operations (HTO) plays a crucial role in providing direct manufacturing quality oversight for Roche's drug product and finished goods. This position involves collaborating with manufacturing and stakeholders to ensure compliance with health authority expectations and industry standards, while also mentoring and coaching team members. The role includes managing discrepancies, supporting internal audits, and leading investigations to uphold quality standards in aseptic drug product manufacturing.

Requirements

• Bachelor's degree in Life Sciences or Engineering (Master's preferred).
• At least 5 years of experience in the pharmaceutical industry for QA Specialist.
• At least 8 years of experience in the pharmaceutical industry for Senior QA Specialist.
• In-depth experience in aseptic GMP Drug Product filling and quality oversight.
• Effective communication skills for handling complex and sensitive information.
• Ability to gown into production space.

Nice To Haves

• Master's degree in Life Sciences or Engineering.

Responsibilities

• Provide direct manufacturing quality oversight at HTO.
• Partner with manufacturing and stakeholders to ensure reliable delivery of products.
• Act as a mentor and coach for the organization.
• Serve as the key quality contact for discrepancy management and batch review.
• Ensure investigations are accurate and include appropriate corrective actions.
• Support internal cGMP audits and Health Authority inspections.
• Develop new approaches to complex problems and influence others to change their point of view.

Benefits

• Discretionary annual bonus based on individual and company performance.
• Relocation benefits available.
• Comprehensive health insurance coverage.
• 401k retirement savings plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree