Quality Assurance Specialist I (MQA)

Genentech • Hillsboro, OR

3d • $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

• 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.
• Able to perform physical activity including, but not limited to lifting, standing for periods of time, and gowning.
• Basic knowledge or familiarity with cGMPs or equivalent regulations.
• Experience or a strong aptitude for reviewing documentation with high attention to detail.
• Able to learn to interpret and relate Quality standards for implementation and review.
• Able to evaluate situations and propose potential solutions.
• Able to communicate clearly and professionally both in writing and verbally.
• Flexible and adaptable approach to problem solving, learning new tasks and meeting business objectives.

Responsibilities

• Provide essential support for manufacturing activities, documentation review, and initial discrepancy support.
• Provide basic Quality Assurance support for routine GMP activities in manufacturing at HTO.
• 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.

Benefits

• The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $55,000 - $102,000.
• Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law.
• A discretionary annual bonus may be available based on individual and Company performance.
• This position also qualifies for the benefits detailed at the link provided below.
• Please note this role is eligible for relocation benefits.
• Link to Roche/Genentech Benefits

What This Job Offers

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