QC Associate I/II

The Position

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!
 

Job Responsibilities:

Perform a broad variety of basic and moderately complex tests with documentation according to GMP

• Review data and assess against established acceptance criteria
• Perform technical review of peer-generated data
• Evaluate data to identify trends and/or establish limits
• Identify discrepancies. Provide input to design of quality investigations and CAPA (corrective actions preventive actions) initiatives as needed
• Identify and troubleshoot technical problems.
• Identify gaps in systems and procedures
• Receive and provide training
• Participate in assay transfer and assay validation
• Perform equipment qualification / maintenance
• Prepare and maintain standards, controls, stocks, cultures, etc. per established procedures
• Support the maintenance and compliance of operational areas.
• Assure and apply GMP throughout operations
• Coordinate with customers to support multi-site operational activities
• Support internal and external audits and regulatory inspections
• Works to meet schedules, timelines, deadlines
• Participate in and/or lead group and project teamwork; project and process improvements
• Write protocols and reports under limited supervision
• Meets scheduled performance of 95% on time.
• Perform other duties as requested by managers to support Quality activities.

Job Requirements:  

• 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.
• Strong verbal and written communication skills, ability to organize and present information both formally and informally.
• 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.
• Physical requirements - Prolonged periods of standing at lab bench top. Frequent lifting (up to 10 lbs), bending, reaching, twisting. Use of step ladders and push carts required.

Position may involve use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.

Relocation benefits are not available for this job posting. 

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

Salary : $74,600 - $94,400