Work Schedule First Shift (Days)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.Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.We are seeking QA Auditors (levels I & II) at our Lab in Gothenburg, Sweden. These roles are fully site based.A day in the life:Conducts and/or leads a variety of client, internal or GxP audits and regulatory inspections as requested by senior managementLeads directed site audits, facility, vendor and/or sub-contractor auditsProvides GxP consultation and support to project teams and external clientsLeads process audits and may participate as a co-auditor in more complex system auditsPerforms other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement)Contacted by others to serve as a resource to operational departments on audit or quality assurance subject matterPrepares and presents audit findings and/or other related information at departmental, internal operations or client meetingsProvides mentorship and guidance to junior auditorsKeys to success:Education and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’).In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.Knowledge, Skills and Abilities:Detailed knowledge of GxP and appropriate regional research regulations and guidelinesDemonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by managementExcellent oral and written communication skillsStrong problem solving, risk assessment and impact analysis abilitiesSolid experience in root cause analysisAbove average negotiation and conflict management skillsFlexible and able to multi-task and prioritize competing demands/work loadValid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travelWorking Environment:Below is listed the working environment/requirements for this role:Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.Able to work upright and stationary and/or standing for typical working hours.Able to lift and move objects up to 25 poundsAble to work in non-traditional work environments.Able to use and learn standard office equipment and technology withproficiency.May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
