Quality Manager - Monday-Friday 8:00am-5:00pm - Eurofins Viracor, LLC

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

Job Description

Basic Function and Scope of Responsibility:

Under the direction of the Clinical Laboratory Director and Director of RA/QA, the Quality Manager will implement and perform functions in support of the Quality Management System (QMS) which assures a foundation for laboratory quality and compliance with federal, state and accreditation bodies to ensure laboratory inspection readiness at all times and provides a basis for long-term continuous improvement.

Essential Job Duties:

• Ensures laboratory compliance with all applicable regulatory and accreditation agencies in collaboration with the Laboratory Director.
• Provide continuous mentoring and coaching of the Quality and Metrology teams, supervisors, CLSs or peers and direct the activities for other laboratory associates to ensure and enhance compliance to established process requirements.
• *Oversee the administration of the clinical laboratory's internal and external proficiency testing programs, including collation of data and ensuring review of results and corrective action, as applicable.
• *Oversee and assist in investigations and closure of non-conforming events, client complaints, and revised reports, ensuring that responses are accurate and complete, as well as ensuring that immediate, short-term, and long-term corrective actions are implemented and documented.
• *Oversee and assist with administration of processes used for management of instrument maintenance activities and environmental monitoring used to ensure compliance with manufacture recommendations and regulatory standards including review of records of completion, and evaluation of patient impact as needed when failures are found.
• Oversee and assist in administration of the critical material process for incoming materials and components, ensuring only qualified manufactured reagents/components are put into use.
• Oversee and assist in administration of the qualification and delegation process for laboratory associates ensuring collection of credentials and review for meeting regulatory standards and requirements and executing requested delegations meet requirements.
• Oversee and assist in administration of the training, competency and continuing education programs ensuring compliance with applicable requirements.
• Assist RA/QA Director with defining, monitoring, and reporting Regulatory and Quality department Key Performance Indicators (KPIs) and improvement metrics and documenting appropriate follow up when metrics do not meet defined parameters.
• Support, implement and ensure compliance of all department and company QMS related policies.
• Perform department quality related activities (PT reviews*, NCE/CAPA review and closure*, reviewing maintenance records*).
• Identify relevant quality-related training needs and facilitate delivery of training with Quality Specialist and department leadership.
• Consistently notifies Management of possible compliance issues and suggests/facilitates corrective actions.
• Hosts Monthly Clinical Quality Meeting and supports Quality Council meetings by ensuring accurate presentation of KPIs and data, minutes are recorded, and any action items are followed-up and presented.
• Monitors and mana