Senior Quality Control Associate- Direct Materials

The Position

Hillsboro Technical Operations (HTO) is a manufacturing organization responsible for the reliable delivery of biologics drug product & finished goods, both for Roche’s commercial portfolio as well as launch products. 

Your Opportunity

In this exciting role, you will be a member of a collaborative team that creates outcomes that matter for patients, customers and the company.  This Direct Material position will join the exciting and fast-paced Quality Control Operations team in Hillsboro Technical Operations. 

Note: M-F day shift position 

Responsibilities:

• You will perform routine testing/review/approval/coordination of Direct Materials

• You will establish, implement and use SOPs, specifications, and testing methods in full compliance with cGMP regulations and evolving expectations 

• You will provide technical input to ensure rapid resolution of any operational/technical issues (discrepancies and deviations)

• You will develop, provide and receive training

• You will lead and/or perform analytical activities (e.g., assay transfer and assay validation) to meet project timelines

• You will support internal and external audits and regulatory inspections

• You will perform technical review of data and assess against established acceptance criteria

• You will identify discrepancies and provide input to the design of quality investigations and CAPA initiatives as needed

• You will participate in and/or lead project teams and process improvements initiatives

• You will establish work priorities to meet targets and timelines; manage competing priorities

• You will serve as representative on cross-functional and multi-site teams

• You will serve as a technical subject matter expert (SME) in support of department functions

• You will notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance

Who you are:

• You have a B.S./B.A. degree and minimum of five years of experience or an equivalent combination of education and experience. Degrees are preferably in Biology, Biochemistry, Molecular Biology or relevant scientific discipline and experience is in pharmaceutical or biopharmaceutical industry

• You have sound knowledge of cGMPs or equivalent Regulations.  A minimum of three years of experience working in a GMP environment is required.

• You must have strong verbal and written communication skills.

• You must have the ability to interpret and apply quality standards to operational activities.

Work Environment / Physical Demands / Safety Considerations

• Prolonged periods of standing at lab bench top. Frequent lifting (up to 25 lbs), bending, reaching, twisting, climbing stairs. Use of step ladders and push carts required.

• Position may involve use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $68,300- $126,900. 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.

Link to Benefits

This position is eligible for relocation benefits

Who we are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

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