Serves as a Quality Partner, responsible for Quality Assurance oversight. Collaborates with Operations and other areas of the business.
Partners in evaluating and investigating nonconformance s, including assessing risk, determining root cause, identifying any corrections, material disposition, and the determination of the need for corrective and/or preventive actions. Also responsible for the review and approval of nonconformance s.
Serves as a Quality Representative partnering, reviewing and approving Change Requests.
Performs an independent quality review of validation documentation.
Reviews and approves document workflows.
Manages workload to ensure manufacturing schedules are met.
Bachelor s degree in Biological Science, Chemistry, Engineering or related field, or equivalent combination of education and work-related experience.
3 to 4 years experience in the diagnostics or pharmaceutical industry dealing with quality
4 to 5 years experience preferred
Quality concepts, cGMPs, knowledge and experience in the IVD, Device, or pharmaceutical industry.
Superior Analytical, interpersonal, communication, organizational and leadership skills
Preferred- Quality Engineer
Who we are 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.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.