Quality Assurance Specialist II (MQA)

Roche • Hillsboro, OR

97d • $67,000 - $125,000

About The Position

Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products. The Quality organization at HTO comprises Quality Assurance, Quality Systems & Compliance, Quality Control, and Quality Engineering & Validation. Together, we produce millions of units of life-saving medicine every year to patients around the world. In this exciting role, you will be part of the Frontline Team (A Shift) in the Manufacturing Quality Assurance. You will act as a key Quality contact to manufacturing for floor support, batch record review and discrepancy management (Quality Incidents and Minor Deviation). You will partner with cross-functional stakeholders at the site. You will provide direct manufacturing Quality Assurance support for all GMP activities at HTO. You will resolve routine Quality Assurance issues limited in scope and complexity following cGMP regulations. You will meet assigned targets and timelines with minimal supervision. You will collaborate cross functional to ensure that all review activities are executed efficiently and effectively. You will support Quality process improvement initiatives.

Requirements

• B.A./B.S. degree (preferably in Life Science) with 2 - 4 years of relevant experience or MS degree (preferably in Life Science) with 2 years of relevant experience.
• Knowledge of cGMPs or equivalent regulations strongly preferred.
• Experience reviewing manufacturing documentation.
• Ability to interpret and relate Quality standards for implementation and review.
• Ability to independently evaluate situations and propose potential solutions.
• Clear and professional communication skills, both in writing and verbally.
• Flexibility in problem solving and work hours to meet business objectives.

Responsibilities

• Act as a key Quality contact to manufacturing for floor support.
• Conduct batch record review and manage discrepancies (Quality Incidents and Minor Deviation).
• Provide direct manufacturing Quality Assurance support for all GMP activities.
• Resolve routine Quality Assurance issues following cGMP regulations.
• Meet assigned targets and timelines with minimal supervision.
• Collaborate cross-functionally to ensure efficient and effective review activities.
• Support Quality process improvement initiatives.

Benefits

• Discretionary annual bonus based on individual and Company performance.
• Relocation benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees