Quality Specialist III

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeAs part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.Discover Impactful WorkJoin Thermo Fisher Scientific in ensuring the highest quality standards across our operations. As a Quality Specialist III, you will support regulatory compliance and drive continuous improvement of quality systems that enable our customers to make the world healthier, cleaner, and safer.You will collaborate with cross-functional teams to investigate quality issues, conduct audits, manage documentation, and implement corrective actions while fostering a culture of quality excellence throughout the organization.LocationThis is a fully onsite role in Sunnyvale, CA with weekly travel to our San Jose, CA site. Relocation assistance is not provided.A Day in the LifeSupport and maintain compliance with GMP/GxP, ISO, and regulatory requirementsInvestigate quality issues and lead root cause analysis effortsManage and support:CAPA processesDeviations and nonconformancesChange control activitiesConduct and support internal and external audits and regulatory inspectionsAuthor and review quality documentation (SOPs, investigation reports, etc.)Perform data analysis, trending, and reporting of quality metricsCollaborate with cross-functional teams to drive corrective and preventive actionsSupport continuous improvement initiatives and quality system enhancementsKeys to SuccessEducationBachelor’s degree in Life Sciences, Engineering, Chemistry, Biology or related technical field with 5+ years of experience in quality assurance/quality control or Advanced degree with 3+ years of relevant experienceExperience:Experience in regulated industries (pharmaceutical, medical device, or biotech preferred)Experience with quality management systems (TrackWise, Document Control Systems), CAPA processes, deviation management, and change controlDemonstrated expertise in root cause analysis, investigation techniques, and corrective action implementationExperience conducting and hosting internal/external audits and regulatory inspectionsProficiency in statistical analysis, data trending, and quality metrics reportingProject management experience preferredKnowledge, Skills, AbilitiesStrong knowledge of GMP/GxP regulations, ISO standards (9001/13485), and other relevant quality system requirementsKnowledge of risk assessment methodologies and continuous improvement toolsStrong technical writing skills for authoring SOPs, investigation reports, and other quality documentationAdvanced problem-solving abilities and attention to detailExcellent verbal and written communication skillsStrong interpersonal skills with ability to collaborate across functions and levelsAbility to work in manufacturing environments with appropriate PPE as neededAbility to work independently and guide cross-functional teamsMay require up to 25% travelOther:Must be legally authorized to work in the United States without sponsorship now or in the futureMust be able to pass a comprehensive background check and drug screenCompensation And BenefitsThe salary range estimated for this position based in California is $90,900.00–$122,000.00.This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:A choice of national medical and dental plans, and a national vision plan, including health incentive programsEmployee assistance and family support programs, including commuter benefits and tuition reimbursementAt least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policyRetirement and savings programs, such as our competitive 401(k) U.S. retirement savings planEmployees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discountFor more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards