Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeJob DescriptionAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking 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.Location/Division Specific InformationOur manufacturing site in Ridgefield, New Jersey, is an integral part of our sterile fill-finish manufacturing network. The site, bolstered by a dedicated team of Pharma Services colleagues, enables our customers to deliver life-changing medicines to patients around the world. The Ridgefield site exemplifies our commitment to quality, patient-safety and innovation in the pharmaceutical industry, making a significant impact on global health.Discover Impactful Work:The Compliance Specialist will be responsible for leading root cause analysis activities, approving deviations reports and providing technical support to Operations. In addition, this role will be responsible for creation, review and approval of CAPAs and Effectiveness Checks.A day in the Life:Lead and Author Investigations: Collaborate with Quality, SMEs, and Manufacturing to determine the scope of investigations, lead investigation teams, and ensure regulatory compliance.Develop and Execute Investigation Strategy: Develop investigation strategies and complete investigations within required timelines, utilizing Root Cause Analysis techniques.Manage Deviations and CAPAs: Classify, review, and approve deviations; create and approve CAPAs to address root causes effectively.Support and Present Investigations: Support investigations of minor non-conformances and present findings to the Management Review Board.Trend Analysis and Recommendations: Trend deviation and CAPA reports, making recommendations based on results.Ensure Safety and Compliance: Promote a safe working environment, support HSE policies, complete required HSE training, report accidents and incidents, and ensure timely closure of HSE actions.Keys to Success:EducationBachelor's Degree with 3 or more years’ experience completed deviations or in a QA EnvironmentExperienceWorking knowledge of cGMPs in pharmaceuticals/biological and aseptic manufacturingPreferred experience with Lean, 5S and Gemba for CAPAPreferred experience with a deviation/CAPA enterprise systemsKnowledge, Skills, AbilitiesExcellent technical writing skillsLeading Investigation TeamStrong analytical and problem-solving skillsMake sound judgement from dataStrong communicatorWorks independently to ensure on-time investigation closureWorking knowledge of Word, Excel, PowerPointBenefits:We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
