Regulatory Affairs Specialist

Global Technical Specialist, Clinical PTThe purpose of this document is to describe the duties, responsibilities, and qualifications of the Global Technical Specialist, Clinical PT. As part of the Technical Support team at LGC Proficiency Testing, Inc. (LGC PT), the Global Technical Specialist supports daily activities related to LGC PT's clinical proficiency testing programs.Main duties and responsibilities include:Provide first line support to PT participants via email in relation to technical questions and requests with the PT reporting system PORTAL, the submission results, and report interpretation.Support the Global Technical Manager in planning, coordinating, and maintaining PT round and shipping schedules.Assist with PT program setup, customer order management, and round configuration within IFS and PORTAL systems.Assist with creation and review of technical documents, including instructions to participants.Assist with review and approval of statistical analysis and evaluation decisions, including technical summaries, expert commentary, and interpretive content as needed for PT program reports.Maintain an awareness of technical developments in the clinical laboratory: assist in identifying new proficiency products in response to industry needs.Maintain familiarity with ISO/IEC 17043. Using appropriate document control measures, assist in maintaining compliance with ISO/IEC 17043 requirements.Minimum qualifications include:Bachelor's degree in Medical Technology, Medical Laboratory Science or equivalentASCP certified or equivalentPreferred qualifications include:Proficiency Testing experienceLGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or maternity, religion, or belief. Short listing, interviewing and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership.For more information about LGC, please visit our website