At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients’ lives. We are courageous in both decision and action, we believe that good business means a better world.
The focus of the Vacaville Operations Facility is Drug Substance bulk manufacturing. We have a passion for science, technology, innovation, professional development, and diversity and inclusion. We are also deeply respected for our unique and special culture; one that centers around the people we attract and hire. Our Pharma vision is to have a greater overall patient benefit and impact. This focus includes personalized healthcare, designing the processes with the patient in mind, and improving their quality of life. We hope you consider joining our team and being a part of one of the largest biotechnology facilities in the world!
As a member of the Vacaville QC Equipment Qualification Team, the QC Associate will be primarily responsible for the support and execution of laboratory equipment qualification and associated computer system validation activities in compliance with current cGMP regulations and Roche/Genentech corporate principles, quality policies, standards, and core values. You will work closely with instrument vendors, facilities, IT and lab personnel to coordinate the acquisition, installation, qualification, and periodic review of laboratory instruments.
Perform qualification of laboratory equipment in accordance with EQ policies, plans and procedures.
Coordinate with laboratory personnel to define qualification requirements.
Author, review and execute equipment qualification protocols.
Coordinate equipment qualification activities with vendors and other support groups.
Coordinate equipment maintenance activities with vendors and other support groups, as required.
Identify business, quality, and compliance gaps and propose and implement potential improvements to systems and procedures
Collaborate and author department policies and procedures.
Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
Provide input to technical / investigation reports.
Participate in and support internal and external audits and regulatory inspections
Identify, troubleshoot, and propose resolution to technical problems.
Identify gaps in and potential improvements to systems and procedures.
Receive and provide training.
Provide input to and participate in assay transfer/validation associated with equipment qualification/lifecycle.
Coordinate with customers to support multi-site operational activities.
Present equipment lifecycle and associated procedures/material during internal and external audits and regulatory inspections.
Works to meet schedules and set timelines.
Participate in and/or lead group project teamwork; project and process improvements.
Perform other duties as requested by managers to support Quality activities.
Education: B.S./B.A degree and three years experience or Masters degree plus one year experience or an equivalent combination of education and experience. Degrees are preferably in relevant scientific discipline and experience is in pharmaceutical or biopharmaceutical industry.
Experience (may vary depending on site size/scope)
Experience with analytical instrument qualification requirements (e.g., USP 1058, 21 CFR Part 820 etc.) and/or computer system validation (e.g., 21 CFR 11, Annex 11 etc.) is desired
Strong verbal and written communication skills, ability to organize and present information both formally and informally.
Experience in the application of risk management principles
Proven ability to make sound decisions about scheduling, allocation of resources, and managing priorities.
Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.
Routinely exercises sound judgement, 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
May be required to sit at a computer for extended periods
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.
Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
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Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
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