Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with usAs a Quality Assurance Specialist II, you will play a critical role in ensuring the integrity and quality of our processes and products. You will work on diverse problems requiring data analysis and evaluation of identifiable factors. This position offers the opportunity to interact with internal and external personnel on significant matters often requiring coordination.Location: IrelandResponsibilities:Review complex batch records and associated documentation for completeness and accuracy.Lead risk assessments and may lead vendor and internal audits.Participate in client and regulatory inspections.Manage the set up and filing of documents.Mentor junior team members in areas of expertise.Serve as a quality consultant to the organization, supporting business leaders in risk mitigation.Build relationships between on-site QA services and QA management of designated clients.Requirements:Minimum of 5 years of experience in clinical auditing or quality assuranceStrong knowledge of GxP regulations and guidelinesExceptional attention to detail and ability to ensure flawless execution of auditsProven ability to successfully implement audit processes and proceduresExcellent communication and presentation skillsOur Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.