Quality Control Associate

Roche • Hillsboro, OR

3d • 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.) 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. Who you are: (Minimum Requirements) BS/BA degree, or minimum of 3 years experience working in a cGMP or similarly regulated environment in the pharmaceutical or science industry. Work Environment/Physical Demands/Safety Considerations: Work in an office and laboratory environment Lift up to 25 lbs may be required. Ability to sit, stand, and move within work space for extended periods May be required to sit at a computer terminal for extended periods. Working location is Onsite. Relocation benefits are not available for this job posting. The expected salary range for this position based on the primary location of Oregon is $52,600- $75,200. Actual pay will be determined based on experience, 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. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants. Who We Are 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. The next step is yours. To apply today, click on the "Apply for this job" button. Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

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