QC Specialist

Genentech•Hillsboro, OR

12d•Onsite

About 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. 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 opportunity you will join a team that is expanding and transferring potency analytical methods to our Quality Control Lab. There is the potential to help establish HTO as a center of excellence for the North American network. This role will give you the ability to use your expertise and mentor/train others. In addition to performing and reviewing microbiological assays, the individual must be able to interpret environmental monitoring (EM) data, troubleshoot assay failures and equipment issues while adhering to strict guidelines on cGMP documentation. In addition the individual will support planned events/unplanned events/out-of specification investigations, EM assessments, and collaborate with external groups to identify improvement opportunities in technology and business processes. Implementing, modifying, and enforcing Quality Control policies, procedures, specifications and testing methods consistent with cGMP, regulations, appropriate compendium, and Roche/Genentech standards, policies, plans, objectives and procedures. Routine sampling, performing, and reviewing a variety of assays in the Quality Control organization in support of In-process, drug product, finished product, raw materials and incoming inspection, and environmental monitoring testing in a cGMP environment. Interprets data, troubleshoots assay failures and equipment issues while adhering to strict guidelines on cGMP documentation. Supports method validation activities, performance qualifications, method transfers, discrepancy/out-of-specification investigations and collaborates with stakeholders to identify improvement opportunities in technology and business processes. Ensure maintenance and calibration of laboratory equipment and systems. Support during cGMP audits and Health Authority inspections as needed, and follow up on any corrective measures is also required.

Requirements

Bachelor’s Degree with 5-7 years experience working in a cGMP or similarly regulated environment in the pharmaceutical or science industry.
3-5 years experience with a Master’s Degree or 0-2 years experience with PhD/JD.

Responsibilities

Performing and reviewing microbiological assays
Interpreting environmental monitoring (EM) data
Troubleshooting assay failures and equipment issues while adhering to strict guidelines on cGMP documentation
Supporting planned events/unplanned events/out-of specification investigations, EM assessments
Collaborating with external groups to identify improvement opportunities in technology and business processes
Implementing, modifying, and enforcing Quality Control policies, procedures, specifications and testing methods consistent with cGMP, regulations, appropriate compendium, and Roche/Genentech standards, policies, plans, objectives and procedures
Routine sampling, performing, and reviewing a variety of assays in the Quality Control organization in support of In-process, drug product, finished product, raw materials and incoming inspection, and environmental monitoring testing in a cGMP environment
Interpreting data, troubleshoots assay failures and equipment issues while adhering to strict guidelines on cGMP documentation
Supporting method validation activities, performance qualifications, method transfers, discrepancy/out-of-specification investigations and collaborates with stakeholders to identify improvement opportunities in technology and business processes
Ensuring maintenance and calibration of laboratory equipment and systems
Supporting during cGMP audits and Health Authority inspections as needed, and follow up on any corrective measures is also required