Senior Quality Control Associate

The Position

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.

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.

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, direct materials and stability sample testing in a cGMP environment. Specifically, biochemical assays, using analytical techniques and instrumentation, such as high performance liquid chromatography (HPLC) and mass spectroscopy. The individual 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 Quality Control inspection, direct material approval and planned events/unplanned events/out-of specification investigations and collaborate with external groups to identify improvement opportunities in technology and business process.

Responsibilities:

• Perform other duties as requested by managers to support QC activities.
• Coordinate, test, and approve direct materials (QCI).
• Coach colleagues and help them develop expertise/skills in related functions.
• Implement improvement opportunities that support of Quality Control.
• Complete and coordinate planned event and unplanned event records.
• Follow company policies and procedures
• Independently manage competing priorities with limited instruction.
• Maintain a state of inspection readiness.
• Serve as the Quality Control primary point of contact.
• Perform testing/review of laboratory assays.
• Participate in cross functional squads representing Quality Control, as assigned.
• Present relevant topics to internal and external regulatory inspectors.
• Apply basic theory and technical principles to address problems.

Qualifications:

• Hands-on industrial laboratory experience with analytical techniques such as HPLC, UPLC.
• Must have the ability to interpret and apply quality standards to operational activities.
• Must have strong verbal and written communication skills.
• BS Degree with at least 5 years of work experience in similar roles.
• Sound knowledge of cGMPs or equivalent Regulations. A minimum of 1 year of experience working in a GMP environment is required.

Work Environment / Physical Demands / Safety Considerations

• Work in an office and laboratory environment.
• Lift up to 25 pounds may be required.
• Ability to sit, stand and move within work space for extended
• Ability to enter data into a computerized system for up to 30% of your time.

This position is eligible for relocation 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.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.