Job Title: Quality Assurance SpecialistDepartment: QualityLocation: Onsite; York, UKHours Per Week: 37.5Schedule: Monday - Friday 9:00 AM - 5:00 PMSUMMARYThe Quality Assurance Specialist is responsible for performing the following duties as directed by the Manager, Quality Assurance.RESPONSIBILITIESIndependently perform a wide range of activities to support the Quality Assurance department by participating the processes required to achieve & maintain the required accrediting agency/standards & regulatory requirements for the organisation.Serve as Quality Assurance contact for assigned customers & functional areas (as required)Support the promotion and compliance with regulations, guidelines, and Standard Operating Procedures within the organisation.Serve as a resource promoting the development of understanding of the key elements related to Quality Management Systems & regulatory compliance requirements including training opportunities to staff at an organisational wide levelMaintain current awareness of all required standards, laws & guidelinesProvide input to the development of Quality Assurance Standard Operating Procedures & processes, the Quality Manual and other organisational Standard Operating Procedures & processes where requiredProvide support and input to development groups for consultation & interpretation of regulations, guidelines, corporate standards & policiesPrepare for, carrying out, report and follow up of Quality Assurance required audits – including internal, 3rd party and vendor audittRecommend systems for audit, write audit plans, coordinate scheduling & closure of internal auditsParticipate in review of root cause analysis, corrective action & preventive action plans for internal, 3rd party & vendor auditsResponsible for ensuring assigned internal audit & vendor audits are completed as scheduled and reporting associated metrics to Quality Assurance management. Monitor the compliance of all departments via routine audits to ensure adherence with internal Standard Operating Procedures & external regulationsParticipate in and support client, regulatory and sub-contractor auditsSupport the processes in place to ensure customer complaints are appropriately raised and handledSupport the processes in place to ensure internally identified Quality Issues are appropriately raised and handledProvide oversight & participate in review root cause analysis, corrective action & preventive action plans for Quality Issues & customer complaintsProvide oversight to the documentation, reporting, effectiveness checks & closure of compliance issues (audits, Quality Issues & customer complaints)Participate in monthly laboratory Quality Assurance meetings. Assist the Manager, Quality Assurance as requiredProvide support to Quality Assurance management with customer-initiated audits & mock regulatory inspections & regulatory facility inspectionsParticipate in Lean/Six Sigma, process improvementsSupport Quality Assurance related activities to ensure a harmonised Quality Management SystemParticipate in Continuous Professional DevelopmentPerform the role of a Deputy Archivist when requiredREQUIRED QUALIFICATIONSBachelor’s Degree in scientific discipline required or requisite experience.Minimum 3 years’ experience in Laboratory Quality Assurance, Pharmaceutical or Clinical Research Organization (CRO) is required.Knowledge of, and demonstrated experience with application of, regulatory agenciesKnowledge of, and demonstrated experience with application of Good Clinical Practice (GCP) guidance is requiredPREFERRED QUALIFICATIONSKnowledge of applicable regulations and standards such as, ISO15189, NEQAS, CAP and CLIA is strongly preferredPHYSICAL REQUIREMENTS:S - Sedentary Work - Exerting up to 10 pounds of force occasionally Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.
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