Senior QA Specialist, Environmental Quality

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.

The Opportunity:

In this exciting role, you will provide Quality oversight for environmental monitoring (EM) and aseptic media fill programs ensuring the programs are consistent with company procedures. You will provide Quality oversight of routine environmental monitoring, air flow studies, pest management, and aseptic media fill activities to ensure adherence to established procedures. You will serve as a subject matter expert (SME) and resource for the site on EM principles and standard practices.

• You will provide guidance to internal and external customers on best practices for executing consistent, reproducible, and compliant environmental control programs

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

• You will provide technical assessment and approval for changes to the environmental control program.

• You will provide Quality authorization for facility and utility restarts following construction or facility wide maintenance.

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

• You will support in the development and preparation of regulatory submissions related to the environmental quality of Genentech manufacturing facilities and processes.

• You will support in the defense of the overall environmental control program and media fills to regulatory agencies.

• You will support training of Manufacturing and Quality on aseptic techniques, environmental monitoring and aseptic media fills and review and approve EM program documentation.

• Collaborate with departments to ensure that EM activities are executed efficiently for nonroutine EM activities.

• Identify, design and recommend control enhancements (i.e cleaning, gowning, pest management), operations improvements, personnel training and other corrective actions as appropriate.

Qualifications / Requirements:

• You hold a B.A. or B.S. degree (preferably in a life science) and a minimum of six years' experience in a 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.

• 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 knowledge of GMP, SOPs, compliance requirements within the manufacturing environment.

• You have strong technical knowledge of the biopharmaceutical manufacturing process and equipment.

• 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 $91,000- $169,000. 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.

Link to Benefits

Relocation benefits are provided

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Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.