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 - enabling 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 through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.We are seeking a QA Auditor (I) for our Labs in Athlone, Ireland. the role is permanent and full-time. The role can be mostly home-based but with a requirement to be on site in Athlone as per business need (approx a few days per month).A day in the life:Audits laboratory data for compliance with methods and standard operatingprocedures and report findingsAudits sample result tables and analytical reports for completeness and accuraterepresentation of the data and report findingsServes as a resource to operational departments on audit or quality assurancesubject matterAssists in the preparation of audit findings and/or other related informationKeys to success:Education and Experience:Bachelor's degree or equivalentPrevious QA or lab experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3-5 years’).Knowledge skills and abilitiesFamiliar with applicable GxP and appropriate regional regulationsDemonstrated ability to perform GxP audits based on SOPs and applicable FDA regulations, ICH guidelines and to all other standards or guidelines applicable to business-related requirements,Demonstrated ability to independently review study documents for compliance with regulatory requirements or organization's procedures (e.g. Informed consents, protocols, CRFs, Source Document Templates, method validations, equipment qualifications)Achieves acceptable standards of quality and meets timelines for QA deliverables and required departmental reportsExcellent oral and written communication skills (including appropriate use of medical and scientific terminology)Very good problem solving, risk assessment and impact analysis abilitiesProficient at negotiation and conflict managementFlexible and able to multi-task and prioritize competing demands/work loadOur Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. 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 with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
