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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.

Responsibilities include 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.

The QC Analyst must be able to Interpret 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 as required.

In this role, you will be an employee of eTeam, working on a Genentech contract.

Available Shifts: Sunday to Wednesday and Wednesday to Saturday, 4x10’s*

(onboarding and initial training period may require Mon-Fri, 5X8s, shift)

Day: 6:30am to 5:00pm

Swing: 11:30am to 10:00pm

Contract duration: 12 months with possible extension up to 3 years

Pay Rate Start: $30

Responsibilities:

• Impacts quality of own work and the work of others on the team; works within guidelines and

policies.

• Maintain a state of inspection readiness.

• Works autonomously with guidance only on complex new assignments.

• Uses ability as a technical/functional expert to contribute in development of concepts and

techniques, and to complete complex assignments in creative and effective ways.

• Perform environmental monitoring and water sampling.

• Has interaction at the Supervisor and Manager levels on matters pertaining to the immediate area of work. Interactions require tact and effective communication skills as they often involve complex and sensitive information.

• Participate in the design and implementation of department and cross-functional initiatives.

• Apply basic theory and technical principles to address moderately complex problems.

• Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross functional partnerships.

• Serve as a technical subject matter expert (SME) in support of department functions.

• Be accountable for behaviors as described in Genentech’s Core, Common, and Critical

Competencies.

• Perform any other tasks as requested by Management to support Quality oversight activities

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.

Work Environment/Physical Demands/Safety Considerations:

• Work in office and laboratory environment. Lift up to 25lbs may be required.

• Ability to sit, stand and move within workspace for extended periods. May be required to sit at a

computer terminal for extended periods.

+ **Strong verbal and written communication skills, ability to organize and present information in a formal and informal group setting.**

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 (https://docs.google.com/forms/d/e/1FAIpQLSdZWlsbfQOvFVIQgHE\_iDzWUTlhZvj6FytIzjS7xq6IGh1H5g/viewform) .