Senior/Principal QA Specialist (Contamination Control, Aseptic Operations and Microbiology)

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 Operations organization at HTO is divided into 2 manufacturing units, which combine to 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 a highly engaged team that is committed to delivering high quality medicines to patients. You will provide Quality oversight for the contamination control strategy, aseptic operations and microbiology. You will serve as a subject matter expert (SME) and resource for the site on aseptic principles including disinfection, environmental control / monitoring.

• You will provide guidance to internal and external customers on best practices for executing consistent, reproducible, and compliant contamination control strategies and contamination remediations.

• You will support validation activities for new facilities and utilities.

• You will provide technical assessment and approval for changes to the contamination control strategy.

• You will provide Quality authorization for facility and utility restarts following construction or facility wide maintenance to ensure the environmental control and monitoring..

• You will provide input to investigations and deviations involving suspect equipment, utility or facility failures.

• You will support the development and preparation of regulatory submissions related to the contamination control strategy and environmental monitoring of Genentech manufacturing facilities and processes.

• You will support training of Manufacturing and Quality on aseptic practices, aseptic processing and aseptic media fills

• You will collaborate with departments to ensure that environmental control and monitoring activities are executed efficiently for nonroutine activities.

Who you are:

• You hold a B.A. or B.S. degree (preferably in a life science)

• For the Senior QA Specialist level, you have a minimum of 8 years' experience in the pharmaceutical or biopharmaceutical industry. For the Principal QA Specialist level, you have a minimum of 11 years' experience in the pharmaceutical or biopharmaceutical industry; or an equivalent combination of education and experience.

• You have an ability to interpret and relate quality standards for implementation and review.

• You have the ability to make sound decisions about Quality and technical subjects.

• You exhibit sound knowledge of cGMPs or equivalent regulations

• You have flexibility in problem solving and work hours to meet business objectives

• You have strong technical knowledge of aseptic practices, aseptic processing, cleanroom behaviors and contamination control strategies.

• You are able to quickly and consistently establish rapport and collaborate effectively with clients, team members and partners.

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $94,000- $174,000 (Senior level) or $114,000- $211,900 (Principal level). 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

Relocation benefits are provided

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Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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