Quality Systems Specialist

Quality Systems Specialist responsibilities include, but are not limited to, the following:Under the direction of the Manager of Regulatory Affairs and Quality Assurance, this position will assist with maintenance of the Eurofins CellTx Quality Management System (QMS).Initiate, investigate, close, track, trend and verify effectiveness of actions with the QMS components, such as quality events (including deviations, complaints, nonconformances, and investigations), audit corrective action records (ACARS), and Corrective and Preventive Actions (CAPAs). Identify high level trends that have an impact to the organization and escalate the issue/incident appropriately. Lead and/or assist in representing Eurofins CellTx with hosting external auditors (client and regulatory-based audits). Provide external auditors with requested information, ensure documentation is complete and accurate, and collaborate with operational staff for tours and interviews.  Assist with facilitation of the licensing, accreditation, and/or certification process.Provide training and support to inter and intra departmental employees. Lead and mentor employees with the various Quality System elements; Assist in New Employee Orientation programs, organizational-wide training, and individual training for elements, including, but not limited to: Good Documentation practices (GDP), Manufacturing, Tissue Practices, QMS components, applicable regulatory standards, annual procedure review, Document Control, Record Review/ Record Management, Training Program elements and customer satisfaction.Assist and facilitate in the development of planned and systemic processes for Continuous Quality Improvement (CQI) throughout the department and organization. Assist in developing long range continuous improvement plans to accomplish quality; evaluate and provide suggestions to improve system efficiencies and effectiveness.Develop and monitor relevant Quality Indicators for the Quality System to be used an input into the Quality Management Review process.Serve internal and external customers as a consultant. Assist management in addressing business needs in quality or regulatory areas by guiding identification of cause, finding best solution, supporting implementation and monitoring.Perform duties and tasks in a timely and compliant manner, ensuring accurate documentation and conclusions.Maintain and utilize sound working knowledge of all program regulations, standards and policies; keep current with all relevant federal, state and local regulations, recalls, and guidance.Ensure all established procedures (OPs, methods, etc.) and regulatory standards are adhered to at all times. Develop or revise standard operating procedures and laboratory policies, as applicable.Assist in organizing and facilitating regularly scheduled training with managers, supervisors, team leaders and staff as needed to educate/ collaborate and implement quality principles and corporate compliance as a strategy.In order to meet Eurofins’s quality policy and goals/objectives, all employees are expected to meet basic expectations of Eurofins’s quality management system including, but not limited to good workmanship, adherence to standard operational procedures, training, good documentation practices, and accurate recordkeeping.Exhibit support of Eurofins CellTx’ business philosophy, leadership values, quality objectives, ethical behaviors, customer care and confidentiality standards at all times.  Foster a positive work environment, modeling professional behavior.Other duties as assigned, when necessary