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Quality Assurance Specialist
2 months ago
A healthier future. It's 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's what makes us Roche.Vacaville is a manufacturing organization responsible for the reliable delivery of biologics drug substances, both for Roche's commercial portfolio as well as launch products. They are joined in their support of Operations by a number of additional functions, including Quality, Safety & Environment, Material Management (Warehousing & Supply Chain), Finance, and People & Culture. All of these groups bring their unique capabilities & perspectives to work together in service of our patients, our employees, and our community. The Opportunity:Assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production. Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them.
Lead/assist with discrepancy investigations as well as interact with interdepartmental contacts on discrepancy assessment, resolution and Quality approval
Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnership, following cGMP regulations and Genentech standards by applying basic theory and technical principals
Provide assistance/oversight to internal and external customers in support of departmental functions
Review and approve controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product
Collaborate with departments to ensure that all review activities are executed efficiently and effectively
Perform any other tasks as requested by management to support quality oversight activities
Who You Are:
Flexibility to work a 12 hour grave shift
B.A. or B.S. degree (preferably in Life Science) At least five years' experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience)
Knowledge of cGMP or equivalent regulations and ability to interpret Quality standards for implementation
Ability to independently evaluate situations and propose potential solutions
Ability to communicate clearly and professionally both in writing and verbally
Adhere to cGMP gowning and safety requirements
The global grade for this position is SE4.Relocation benefits are not available for this position.The expected salary range for this position based on the primary location of Vacaville, California is $54,300 to $100,800. 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.BenefitsGenentech 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.
