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Quality Manager FTC 18 Months

 

Quality Manager FTC 18 Months

A new Very High Throughput COVID DHSC testing facility requires a strong Quality Manager with experieince of working in a Laboratory environment to join their team.

This is a fixed term contract of 18 months.

As the Quality Manager you will support the Senior QA Manager/Head in Accreditation and Quality Assurance matters on the Leamington Spa Megalab site.

Key Responsibilities:


  • Support the Senior QA Manager in maintaining compliance of the Quality processes and documentation at Leamington Spa Megalab to meet the requirements of the Notified Bodies/UKAS.
  • Support continuous improvements in the Quality Management System (QMS) at Leamington Spa Megalab.
  • Work with the managers and their teams to maintain all aspects of the QMS e.g., Change Controls, Non-Conformities, CAPAs, Customer Complaints
  • Provide support as required for all Notified Bodies/UKAS and Client audits.
  • As the Quality Manager you will work with other QA staff to provide all the support required by the Operations teams, e.g., Work Instruction review, report review, QA statements, training, quality record review.
  • Perform internal audits according to the provided schedule.
  • Perform desk-based and on-site audits of sub-contractors and suppliers.
  • Provide support to ensure timely release of results and audited reports to clinicians.
  • Assist in training of personnel on all aspects related to the QMS.
  • Support the collection and reporting of monthly Quality KPIs.
  • Maintain thorough knowledge and understanding ISO 15189 requirements, Regulatory expectations and guidance documents as these pertain to the work performed at the Leamington Spa Megalab
  • At all times, adopt a safe behaviour by exercising due regard for the health and safety of yourself, colleagues and clients, in line with the Company’s policies and procedures.

Current Challenges and Opportunities:


  • Support the development and implementation of a new QMS to ensure that Regulatory requirements are met whilst maximising work throughput.
  • Develop and implement SOPs etc.
  • Helping to train staff
  • Helping to implement a “right first time” culture throughout the site

Experience/Competence Requirements:


  • Significant experience of operating within ISO Quality Management Systems of operational laboratory environments.
  • Experience with ‘Ideagen Qpulse’ Quality Management System would be a preference
  • Experience in liaising with internal and external stakeholders on all areas of quality and compliance.
  • Experience in conducting audits and hosting external auditors.
  • Experience working within a laboratory setting working to relevant ISO accreditation standards; ISO 15189, ISO 17025, ISO 9001.
  • A team player, with good analytical reasoning, customer focus, communication and change orientation in a fast-paced environment.

 

Please be aware that BPSS (Baseline Personnel Security Standard) including a media check, is the required level of screening for all staff working at the Leamington Spa Laboratory.