Job TitleQuality Assurance SpecialistRequisitionJR Quality Assurance Specialist (Open)LocationDublin, IRLAdditional LocationsJob Description SummaryThe Quality Assurance Specialist is responsible for maintenance of the Quality Management Systems within the College Park manufacturing facility. This position will have a wide range of tasks which include the performance of investigations related to deviations, nonconformances, and out-of-specification/out-of-trend events. The Quality Assurance Specialist will also own and/or lead the corrective and preventive actions that are identified as a result of those investigations. This individual is responsible for the trending and metric reporting of the quality management system elements at the College Park manufacturing facility. The Senior Quality Assurance Specialist will also serve as a lead on quality projects and as the quality representative on site-wide projects or those assigned by management.Job DescriptionPrincipal ResponsibilitiesPerform and evaluate trending of the Quality Management Systems to support management reviews, investigations, and continuous improvement initiatives (i.e. quality management reviews, annual product quality reviews, trend analysis for quality events, etc.)Interpret and properly apply all applicable regulatory requirementsLead and/or support investigations through cross functional team involvement (i.e. RCA, etc.)Present investigations and deliver disposition recommendations to site leadership and Qualified Persons.Improve existing procedures or create new procedures to align with cGMP and regulatory requirementsReview and approve procedures, protocols, reports, etc., as requiredLead and/or assist with continuous improvement, compliance-based, and site projectsSupport lean manufacturing initiatives both at the site level and within the greater Quality/Operations organizationParticipate in internal audits as an SME or member of the audit teamParticipate in External audits as a member of the audit teamPerform additional duties as directed by managementApproval of Change Proposals for GMP impacting changes on site at CPMFSupport the day to day management for QA Team and associated workload.Department specific/Non-essential responsibilities:Support other Quality functions at the site through cross-training opportunitiesDrive Continuous Improvement projects on site from a Quality PerspectiveEnsure Compliance with current regulatory requirementsMinimum RequirementsExperience / Skills:Bachelor's degree or higher in a scientific discipline (biology, chemistry or engineering)2+ years of experience in a cGMP environmentEffective communication, coaching/mentoring, and presenting skillsAbility to manage changeSelf-motivatedIndependent and sound decision making capabilitiesTeam-orientedProject Management skillsAbility to utilize statistics at a moderate level for trending and interpretation of statistical dataDeliver on-time results / Time ManagementCompetencies/Certifications:Proficient with the Microsoft Office Suite, especially Excel, Word, and PowerPointTechnical writingTechnical competency in analytical testingOrganizational Relationship/Scope:The Quality Assurance Specialist collaborates closely with Manufacturing, Quality Control, EHS, Engineering, and Maintenance. This individual must be able to perform in a fast-paced environment with strict adherence to timelines. This position's working hours are during normal site hours M-F, but may be required to work extra hours or on weekends or holidays in order to support site activities. This position reports directly to the Quality Assurance Lead.Working Conditions:The Quality Assurance Specialist will mainly work in an office environment but will also be required to work in the manufacturing and QC environments when providing QA support to those functional areas.Disclaimer:The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.LI-KD1