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QA Coordinator

5 months ago

London, United Kingdom Unilabs Full time

Unilabs, one of the largest diagnostic providers in Europe, is seeking a QA Coordinator to join their team. As a company dedicated to providing comprehensive diagnostic services, Unilabs offers laboratory, imaging, and pathology specialties within one group. With a focus on their CARE BIG culture, Unilabs prides itself on fostering an environment of open-mindedness and innovation.

As the QA Coordinator, you will play a vital role in ensuring the quality of the company's operations. Your responsibilities will include coordinating and implementing quality assurance activities, evaluating processes, and identifying areas for improvement. You will work closely with different departments to develop and maintain quality standards, policies, and procedures. Additionally, you will be responsible for conducting internal audits to ensure adherence to regulatory requirements and industry best practices.

This is an excellent opportunity for someone with a background in quality assurance within the hospital and healthcare industry. If you are passionate about delivering high-quality diagnostic services and have a keen eye for detail, this role is perfect for you. Join Unilabs and contribute to their mission of providing accurate and timely diagnoses while maintaining the highest standards of quality.

Responsibilities

ISO Statement

The QA Coordinator is responsible in ensuring and promoting awareness of the quality management system requirements throughout the laboratory organisation and ensure compliance with ISO 15189 standards in addition to the United Kingdom Accreditation System (UKAS) regulation. Also, the coordinator should be familiar with the Royal College of Pathologists (RCP) and the Institute of Biomedical Science (IBMS) guidelines.

Accreditation

·        This designation aims to monitor the Quality Management System and compliance with local regulations, accreditation requirements and best practice

·        Share updates and document changes on regulatory or accreditation requirements with QA Manager and relevant department

Local Regulation, Mission, Goal

·        Quality Coordinator reports to the Quality Manager and facilitate the Quality Program across Unilabs.

·        To work in line with the company's objectives, strategy and management systems for quality, environment, information security and health and safety and to participate in their operation and development

Advisory and Consultation

·        Provide advisory on implemented policies and procedure

·        Conduct training or counselling on accreditation standards and local regulatory requirements

·        Advising on the development and implementation of the quality policy;

Training

·        Provide training and guidance in the use of the quality management system to include document management, non-conformance and relevant process controls (QC, Proficiency Testing, and Test Method Validation).

·        Support relevant managers during the introduction of newly hired and contracted personnel to QMS

·        Ensures that all personnel involved with Adverse Event from identification to processing and reporting at country level are properly trained.

QMS Implementation

·        Ensure that the quality management system is maintained and complied with, through audit and participation with continuous improvement work.

·        Support QA Manager and operations managers with information about news and changes to the quality system and implementation of new standards within each area of operation

·        Contribute to the completion of quarterly/annual reports and management reviews

·        Support and guide managers and employees in quality assurance work within the respective field of activity

·        Collect and compile statistical quality data to use when analysing the Quality Management system and Quality objectives.  Participate in local management's review of the quality and environmental management system

RA

·        Demonstrate awareness of regulatory standards related to quality.

·        Follow relevant developments and assess practical implications of changes in laws and regulations

Continuous Improvement

·        Drive process improvement in the laboratory process to increase efficiency and productivity by working with technical and non-technical department to identify opportunities for improvement

·        Contribute to the business operations and/or realization of business objectives by advising the management on the development, implementation and execution of the quality and risk management policy, in compliance with company policy and applicable laws and regulation and ensuring adequate assurance and testing

·        Participate in and substantively support established working/project groups

·        Analyze data to identify areas for improvement in the quality system

·        Work closely with the Medical Heads of Section to identify performance issues and workflow improvements

·        Within own area of focus participate in relevant consultation frameworks and possible improvement projects

·        Follow the technical and scientific development in the field of quality and contribute to the implementation of new findings of importance to the organisation in the practical work. 

Policy and Procedure Development, Document Management

·        Maintain document control system to include up to date upload, revision, distribution of written procedures, forms and other related documents

·        Carry out document control of the Quality Management System according to the established procedure to guarantee the validity and application of the documents

·        Codify documents; Ensure document control. Ability to create general policies, Quality policies as per international and local standards

·        Designing and improving operational aids (manuals, procedures and operating methods, etc.) and integrating them into the quality management IT tool.

·        Support in the development and improvement documents. When so required, support the quality manager with drafting quality management policies and procedures

KPI

·        As requested by clients and approval of QA Manager share performance indicators

·        Generate and review key performance indicators. Work or follow up with relevant department on investigating failed metrics and provide reports to the Quality Manager for metrics requiring improvement

·        Monitor and analyze the measurement of the company's indicators to contribute to the fulfillment of established objectives and/or improvement actions

Non-Conformance Management

·        Ensures that the Group Adverse Event procedure and work instructions are properly implemented and maintained in all Unilabs sites of the country.

·        Recording and monitoring non-conformities and corrective actions

·        Answering complaints from the County Governor, and work with operations to collect information on complaints and claims filed

·        Ensure that unwanted incidents, suggestions for improvement at your own unit are dealt with in a timely manner

·        Manage complaints and claims from patients and/or clients to ensure compliance with the company's services and procedures according to established quality standards

·        Register non-conformities, complaints and suggestions following with local regulation and Group requirements

·        Prepares the Monthly Adverse Event Report and submit it to the QA Manager

·        Participate in the reporting, handling of deviations, focus groups, root cause analysis

·        Assist Customer Support or Sales Team on relevant queries from clients

·        Detect nonconformities, adverse events and opportunities for improvement according to established
procedures to ensure corrective actions and/or improvements in the company

·        Develop, recommend and monitor corrective and preventive actions

·        Maintain and control non-conformities registry and keep records of quality reports, statistical reviews and relevant documentation

·        Carry out analysis of the non-conformities reviewing trends and identify risks and produce reports to describe status of non-conformities to share with individual departments and/or Unilabs Management

Process Control

·        Prepare, control and archive the list of Approved Suppliers as a Quality record

·        Support relevant team in preparation of analytical Control Plan to include preparation of verification protocols, method sheets etc..

·        Ensure that adequate internal and external quality control of methods is carried out and that results are monitored

·        Together with the person in charge, monitor that given instructions for internal and external control management are followed, and that continuous reporting takes place to the physician responsible for the method

·        Work with Technical team in implementing and monitoring of internal and external quality control program, completeness of method verification and validation records, proper QC documentation of review, acceptance, and investigation

Audits

·        Responsible for internal audits, quality system reviews and revision of the quality and environmental manual

·        Conduct local internal audits and assist as auditor at other units as needed

·        Assess and monitor safety practices, quality control processes, equipment management through internal audits to ensure audit or assessment readiness and compliance to regulatory and accreditation requirements

·        Participate and coordinate internal inspections to ensure inspection readiness

·        Assist QA Manager in the logistics coordination of inspection, audit, or assessment

·        Monitor and follow up completion and closure of inspection and audit findings for both internal and external assessments or inspection

·        To implement and maintain a program of internal audits against defined quality performance measures and ensure that effective immediate and follow up actions are taken

·        Participate as auditor or auditor assistant in internal audits of processes for ISO or other external quality audit

·        Produce audit reports and conclusions from internal audits of processes for ISO

·        Monitor the yearly audit plan

·        Assist with the administration and coordination of regular Medical Audits and ensure reports and summaries are available in a timely manner

Supply Chain and Procurement

Provide guidance to Supply Chain and Procurement Department on accreditation or regulatory requirements in overseeing supplier selection and evaluation

Equipment Management

Provide guidance to Biomedical and Facility on accreditation or regulatory requirements in overseeing instrument and equipment

Risk Management

Perform risk assessment on different department and maintain risk registry

Human Resources

·        To participate in the workload and assist in controlling the quality and accuracy of the work output

·        To undertake ‘Training and Development Reviews’ and staff appraisals on the laboratory staff as directed by the QA Manager

Customer Service

Assist Customer Support or Sales Team on relevant queries from clients

Operations

None

Reporting Lines , Channels, Membership

·        Preparatory participation in the management review and all elements necessary for the review

·        Supporting medical management with administrative tasks, statistics etc.

·        Chair local quality committees

·        Member of the overall quality committee and prepare meeting minutes, quality summary report

·        Participate in regular internal meetings and trainings as quality manager organizes

·        Oversee correct recording/handling of reports; report periodically to management

·        Assist the Quality Manager and CMO with other ad hoc project work within the department

·        Support the medical management team with administrative tasks.

General Statement

·        Carry out the required tasks in conjunction with the QA Manager

·        Comply with other, unspecified responsibilities necessary to pursue the objectives of the Company or Group

Requirements

  • Bachelor's degree in a relevant field, such as healthcare management or quality assurance.
  • Proven experience in quality assurance within the hospital and healthcare industry.
  • Strong knowledge of regulatory requirements and industry standards, including ISO 15189 and UKAS
  • Familiarity with RCP and IBMS guidelines.
  • Excellent analytical and problem-solving skills.
  • Attention to detail and the ability to maintain accuracy in a fast-paced environment.
  • Strong communication and interpersonal skills.
  • Ability to work independently and prioritize tasks effectively.
  • Proficient in using quality management software and tools.