Sr QA Specialist - Quality Risk Management

Senior Quality SpecialistAs 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.Excellent Benefits PackageReview our company's Total RewardsMedical, Dental, & Vision benefits-effective Day 1Paid Time Off & Holidays401K Company Match up to 5%Tuition Reimbursement – eligible after 90 days!Employee Referral BonusEmployee Discount ProgramRecognition ProgramCharitable Gift MatchingCompany Paid Parental LeaveCareer Advancement OpportunitiesLocation/Division Specific InformationGreenville, NCRELOCATION ASSISTANCE IS NOT PROVIDEDMust be legally authorized to work in the United States WITHOUT SPONSORSHIP OF ANY KIND NOW OR IN THE FUTURE.Must be able to pass a comprehensive background check, which includes a drug screen.Discover Impactful Work:As a Senior Quality Specialist, you will provide technical leadership and oversight within GMP manufacturing environments.

You will partner cross functionally to drive quality excellence, ensure compliance with global regulatory requirements, and strengthen quality systems that support safe and effective products.A Day in the Life:Serve as a subject matter expert on GMP quality systems and regulatory expectationsConduct risk assessments using quality risk management principlesLead and support deviation investigations, including root cause analysisManage CAPAs to ensure effective and timely resolutionEnsure compliance with FDA, EMA, and global regulatory standardsSupport and host regulatory inspections and customer auditsCollaborate with manufacturing, validation, and engineering teams to drive continuous improvementContribute to data integrity initiatives and computer system validation activitiesKeys to Success:EducationAssociate degree or bachelor's degree in business administration, Data Science, Organizational Psychology, Life Sciences, or a closely related field.Experience7+ years of experience in the pharmaceutical or medical device industry, with experience in quality systems, including risk management, manufacturing, validation/engineering, quality assurance, or other relevant areas within a GMP regulated medical device or combination product industryProven expertise in authoring and managing a combination of deviations, CAPAs, change controls, and document control workstreamsExperience with risk assessment methodologies and root cause analysisExperience hosting regulatory inspections and customer audits preferredData integrity and computer system validation experience preferredKnowledge, Skills, AbilitiesStrong knowledge of FDA, EMA, and global GMP regulations (including 21 CFR Parts 210/211, 21 CFR Part 820, ISO 13485, and ICH guidelines)Proficiency with quality management systems and standard office softwareExcellent technical writing and documentation skillsStrong verbal and written communication skillsDemonstrated project management and organizational capabilitiesStrong analytical and problem-solving skillsAbility to work independently and collaboratively across diverse teamsCustomer focused mindset with strong attention to detailFluency in English required; additional languages are a plus