Sr. Quality Control Analyst
About The Position
Roche is a leading research-focused healthcare group with 94,000 employees across 100 countries, dedicated to transforming patients' lives through innovation, curiosity, and diversity. Genentech, a member of the Roche group, is a biotechnology industry founder focused on groundbreaking science to discover and develop medicines for serious diseases, including the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. Diversity and Inclusion are central to their success, fostering an environment where every employee feels valued and can contribute their best. Hillsboro Technical Operations (HTO) is a drug product and finished goods manufacturing organization responsible for delivering Roche’s commercial portfolio and pipeline products. The Operations organization at HTO has two value streams producing millions of units of medicine annually. The Senior Quality Control Analyst within the Operations group of the Quality Control Organization supports all HTO QC activities, focusing on testing and executing tasks assigned by group leads, senior analysts, and/or QC management. This role is crucial for maintaining functional QC operations and supporting all manufacturing and business testing needs.
Requirements
- 5-6 years experience working in a cGMP or similarly regulated environment in the pharmaceutical or science industry OR 3 years of experience working in a cGMP or similarly regulated environment in the pharmaceutical or science industry with a Bachelor's Degree
- Proficiency gained through technical training and regular application, on-the-job experience
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
- Interpreting data, troubleshooting 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 collaborating 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 following up on any corrective measures
Benefits
- Relocation benefits are provided
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
5,001-10,000 employees
