Senior QA Specialist, Lot Disposition

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 value streams, 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 dynamic and inclusive team. You will perform batch disposition activities for products produced at Genentech's Hillsboro, OR facility in accordance with established processes and procedures, performance metrics and adherence to schedule.In addition, you will be responsible for managing the master data related to Quality. You will partner with stakeholders at the site and in the network.

• You will manage batch disposition activities to ensure that products are dispositioned in accordance with cGMPs, Regulatory, and Genentech Policies and Procedures and while maintaining adherence to schedule. This includes cross functional collaboration at the site and with the global Roche/Genentech network to ensure that batch disposition items meet our standards and the final review and approval of batch release documentation.

• You will act as key quality contact to manage Quality master data.

• You will apply your in-depth practical and conceptual knowledge in manufacturing and quality functional areas at the site and within the company network.

• You will ensure that investigations are accurate, include appropriate corrective actions, and follow company standards.

• You will support internal cGMP audits and Health Authority inspections.

• You will develop new approaches to complex problems potentially influencing others to change their point of view and leading others to solve the problem through coaching conversations.

Who you are:

• You hold a Bachelor's degree (preferably within the Life Sciences or Engineering) and have at least 8 years of experience in the pharmaceutical industry.

• You have in-depth industry experience in batch release processes and discrepancy management

• Your interactions exhibit tactful and effective communication skills as they often involve complex and sensitive information.

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $94,000 - $174,000. 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.

This position is eligible for relocation benefits. It is not eligible for full time remote work arrangements.

Link to Roche/Genentech Benefits

#gnehtoquality

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.