Quality Assurance Manager

5 days ago

Lenexa, Kansas, United States Eurofins Viracor, LLC Full time
Job Title: Quality Manager

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.

Key Responsibilities:
  • 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 manages Quality team processes relative to agreed upon goals. Work with individuals and/or team to develop creative solutions to maintain the quality and meet goals.
  • Collaborate with other leaders on strategic planning for process improvements by partnering with management.

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