Quality Control Associate

Genentech • Hillsboro, OR

1d • Onsite

About The Position

At Roche, we advance science so that we all have more time with the people we love. Become a Genentech/Roche member of a collaborative team that creates outcomes that matter for patients, customers and the company.
The Opportunity:
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.)

Requirements

• BS/BA degree, or minimum of 3 years experience working in a cGMP or similarly regulated environment in the pharmaceutical or science industry.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level