Senior Quality Control Analyst (Contractor)

Genentech • Hillsboro, OR

115d

About The Position

A healthier future. It is what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That is what makes us Roche. 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 complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society.

Requirements

• B.A. or B.S. degree (preferably in Life Science) and at minimum 3 years' experience in a cGMP pharmaceutical, biopharmaceutical industry.
• Hands-on industrial laboratory experience with aseptic sampling and testing techniques.
• Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.
• Routinely exercises sound judgment, reasoning and problem solving.
• Capable of working under moderate supervision and determining own short-term priorities.

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 as required.
• Maintaining a state of inspection readiness.
• Working autonomously with guidance only on complex new assignments.
• Participating in the design and implementation of department and cross-functional initiatives.
• Troubleshooting and initiating the resolution of Quality issues by fostering effective interdepartmental and cross functional partnerships.
• Serving as a technical subject matter expert (SME) in support of department functions.
• Performing any other tasks as requested by Management to support Quality oversight activities.

Benefits

• Contract duration: 12 months with possible extension up to 3 years.
• Pay Rate Start: $30.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree