Senior Microbiology Quality System Specialist

Company Description

Eurofins Scientific is an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the leading global emerging players in specialty clinical diagnostic testing.

In 2018, Eurofins generated 4.2 billion Euro proforma turnover in 800 laboratories across 47 countries, employing about 45.000 staff.

Eurofins stands for a conception of clinical diagnostics entirely focused on excellence, innovation and technological investment. Eurofins clinical diagnostics offers testing services in all medical specialties. 

As a central element in healthcare, clinical diagnostics contributes to every stage of patient care: predisposition, prevention, diagnostics, treatment monitoring and prognosis. 

With hundreds of thousands of clinical diagnostics tests performed every day, the laboratories of the clinical diagnostics division strive to ensure that every patient, wherever he or she lives, has access to the most specialized and most innovative techniques for diagnosis, monitoring and therapeutic adjustment. Our logistics expertise and our daily sample collection and delivery network, guarantee perfect continuity in the provision of care while ensuring the same standard of quality and access to innovation across all the regions we serve.

Job Description

Senior Microbiology Quality System Specialist responsibilities include, but are not limited to, the following:

• Under the direction of the Director of Microbiology and Quality Assurance, this position will assist with the design, implementation and maintenance of the Eurofins DPT Quality Management System (QMS) within the Microbiology department.
• In coordination with the Quality Assurance Team, initiate, investigate, close, track, trend and verify effectiveness for Microbiology-related complaints, events (including deviations, waivers and investigations), audit corrective action records (ACARS), and Corrective and Preventive Actions (CAPAs).
• Represent Eurofins DPT in supporting role for client and regulatory-based audits/inspections. Provide external auditors with requested information, ensure documentation is complete and accurate, and collaborate with operational staff for tours and interviews.
• Provide training, mentorship and support to inter and intra departmental employees with the various Quality System elements, including but not limited to New Employee Orientation, organizational-wide training, Good Documentation practices (GDP), QMS components, Document & Record Control & Management, Training Program elements, and customer satisfaction.
• Assist and facilitate in the development, 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 Microbiology Quality Indicators for the Quality System to be used an input into Quality Management Review process.
• Serve as a consultant for internal and external customers. Assist RA/QA 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.
• Develop or revise standard operating procedures and/or policies, as applicable, to ensure quality and regulatory requirements are incorporated into the QMS.
• Identify high level or other Micro-related QMS changes that may have an impact to the organization and escalate the issue/incident appropriately.
• Assist in organizing and facilitating regularly scheduled training with department 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 DPT’s quality policy and goals/objectives, all employees are expected to meet basic expectations of Eurofins DPT’s quality management system including, but not limited to good