Quality Assurance Specialist I (MQA)

Genentech • Hillsboro, OR

8d • $55,000 - $102,000

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.
The Opportunity
In this exciting role, you will be part of the Frontline Team in the Manufacturing Quality Assurance. You will contribute to core Quality tasks by providing essential support for manufacturing activities, documentation review, and initial discrepancy support. You will learn to partner effectively with cross-functional stakeholders at the site.
You will provide basic Quality Assurance support for routine GMP activities in manufacturing at HTO.
You will partner with experienced team members to provide floor support, initial batch record review steps, and discrepancy management (Quality Incidents and Minor Deviations).
You will resolve routine Quality Assurance issues limited in scope and complexity following cGMP regulations.
You will execute daily tasks and complete documentation review with low to moderate supervision.
You will collaborate cross functionally to ensure that all review activities are executed efficiently and effectively.
You will support Quality process improvement initiatives by contributing data collection or assisting with minor tasks as directed.

Requirements

• You hold a B.A./B.S. degree (preferably in Life Science) with 1-3 years of relevant experience in a regulated environment, or an equivalent combination of education and experience.
• You are able to perform physical activity including, but not limited to lifting, standing for periods of time, and gowning.
• You have basic knowledge or familiarity with cGMPs or equivalent regulations.
• You have experience or a strong aptitude for reviewing documentation with high attention to detail.
• You are able to learn to interpret and relate Quality standards for implementation and review.
• You are able to evaluate situations and propose potential solutions.
• You are able to communicate clearly and professionally both in writing and verbally.
• You have a flexible and adaptable approach to problem solving, learning new tasks and meeting business objectives.

Responsibilities

• provide basic Quality Assurance support for routine GMP activities in manufacturing at HTO
• partner with experienced team members to provide floor support, initial batch record review steps, and discrepancy management (Quality Incidents and Minor Deviations)
• resolve routine Quality Assurance issues limited in scope and complexity following cGMP regulations
• execute daily tasks and complete documentation review with low to moderate supervision
• collaborate cross functionally to ensure that all review activities are executed efficiently and effectively
• support Quality process improvement initiatives by contributing data collection or assisting with minor tasks as directed

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees