QC Associate, Master Data

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients' lives. We are courageous in both decision and action; we believe that good business means a better world.

The focus of Hillsboro Technical Operations (HTO) is Drug Product manufacturing (Component Prep & Compounding, Liquid/Lyophilized Filling, Automated/Manual Inspection, Packaging/Finished Products and Distribution.)

Responsibilities include performing and reviewing a variety assays in the Quality Control organization in support of In-Process intermediates, drug product, complaint, environmental monitoring and stability sample testing in a cGMP environment. In addition, biochemical assays, using analytical techniques and instrumentation, such as high performance liquid chromatography (HPLC) and mass spectroscopy. The QC Associate must be able to interpret data troubleshoot assay failures and equipment issues while adhering to strict guidelines on cGMP documentation. In addition the individual will support cycle development, performance qualifications, method transfers, discrepancy/out-of specification investigations and collaborate with external groups to identify improvement opportunities in technology and business process.

The Opportunity:

• Follow company policies and procedures. Maintain a state of inspection readiness.

• Provide input to the development of personal performance goals and departmental objectives Collaborate with Leadership to establish and meet targets and timelines.

• Independently manage competing priorities with limited instruction. Serve as a Quality representative on cross-functional and multi-site teams.

• Identify and recommend solutions to potential procedure, process and system gaps. Provide assistance to customers in support of departmental functions.

• Participate in the design and implementation of department and cross-functional initiatives. Apply basic theory and technical principles to address moderately complex problems.

• Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross functional partnerships.

• Serve as a technical subject matter expert (SME) in support of department functions.

• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.

• Be accountable for behaviors as described in Genentech's Core, Common, and Critical Competencies. Perform any other tasks as requested by Leadership to support Quality oversight activities

Who You Are:

• B.A. or B.S. degree (preferably in Life Science) and at least 3+ years' experience in the pharmaceutical, biopharmaceutical or related industry, or an equivalent combination of education and experience

• Hands-on industrial laboratory experience with analytical techniques such as HPLC, Mass Spectroscopy. Strong verbal and written communication skills, ability to organize and present information informal and formal group setting.

• Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.

• Routinely exercises sound judgment, reasoning and problem solving.

• Capable of working under moderate supervision and determining own short term priorities. Work Environment/Physical Demands/Safety Considerations

• Work in office and laboratory environment. Lift up to 25lbs may be required.

• Ability to sit, stand and move within work space for extended periods. May be required to sit at a computer terminal for extended periods.

Relocation benefits are available for this position.

The expected salary range for this position based on the primary location of Oregon is $66,200 to $122,900. Actual pay will be determined based on experience, 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.

Benefits

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.