Change Control and Quality Systems Specialist
Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeJob DescriptionAs 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.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: This role focuses on ensuring quality and compliance within regulated environments while supporting continuous improvement and operational excellence across quality systems. A Day in the Life: You will support quality systems, manage compliance activities, participate in audits, and contribute to continuous improvement initiatives across regulated environments. What to expect: Manage and support quality systems including CAPA, deviations, and change controlEnsure compliance with GMP/GxP regulations and ISO standardsConduct and support internal and external auditsDevelop and maintain quality documentation such as SOPsAnalyze data and report on quality metricsCollaborate with cross-functional teams to drive improvementsKeys to Success: Education Associate or Bachelor degree in Business administration, Data Science, Organizational Psychology, Life Sciences, or a closely related field and a minimum of 4 years of work experience within Quality Assurance and/or ManufacturingExperience Minimum of 4 years of experience within pharmaceutical industry with combination products or medical device experience strongly preferredMinimum of 2 years of combined work experience in change management, program/portfolio management, documentation, risk management, or relevant business areas within the pharmaceutical or healthcare industryAdvanced problem-solving abilities and attention to detailExcellent verbal and written communication skillsStrong interpersonal skills with ability to collaborate across functions and levelsProficiency with quality systems software such ...