QUALIFICATIONS & EXPERIENCE:

• Degree or equivalent experience in life sciences, healthcare, or quality.
• Quality management or compliance training desirable.
• Industry Knowledge: Prior experience working within the fertility industry, with a solid understanding of HFEA regulations.
• Quality Assurance Experience: Demonstrated experience in a quality assurance role, ideally within a clinical or laboratory setting, with a focus on documentation and compliance.
• Attention to Detail: Exceptional attention to detail, with the ability to identify and address discrepancies in donor files and documentation.
• Communication Skills: Strong written and verbal communication skills, capable of liaising with various departments to ensure the timely resolution of any outstanding issues related to donor files.
• Process Improvement: Proven ability to contribute to process improvements, particularly in developing or refining policies and SOPs.
• IT Proficiency: Comfortable using data management systems, with the ability to accurately record, track, and analyse data.

ABOUT THE ROLE:

This role will work closely with the Laboratory and Operations Manager as well as donor coordination, clinical, and quality teams to maintain exceptional standards of data integrity, regulatory compliance, and operational efficiency. The successful candidate will play a key role in ensuring that every donor file meets both HFEA requirements and internal quality standards, supporting the overall success and sustainability of the donor programme.

KEY RESPONSIBILITIES:

• Donor File Quality Review: Conduct detailed reviews of donor files to ensure all required documents are accurate, complete, and compliant with regulatory and internal standards before publication. Coordinate with the donor coordination team to address any discrepancies or missing information.
• Liaison with Clinical Teams: Collaborate with genetic counsellors, consultants, phlebotomists, and other clinical team members to gather outstanding information required for donor publication.
• Quality Documentation: Maintain high-quality standards in donor documentation, advising on and implementing necessary changes to ensure compliance and streamline the publication process.
• Support Operational Fluency: Assist the Laboratory and Operations Manager in maintaining an efficient donor programme, contributing to the achievement of KPIs related to donor file quality and publication timelines.
• Data Management and Recording: Ensure accurate and consistent data recording across all relevant platforms for easy tracking and statistical analysis, supporting the reduction of redundant checks in the publication process.
• Process Improvement: Identify opportunities for improving existing quality assurance processes, supporting the development and implementation of more efficient data capture, review, and publication procedures.
• Policy and SOP Review: Assist in the development, review, and maintenance of policies, procedures, and SOPs related to donor qualification, disqualification, consent extensions, and data management, ensuring they remain current and compliant with HFEA standards.
• Internal Auditing and Quality Monitoring: Participate in internal auditing activities, ensuring compliance with quality policies, objectives, and indicators. Monitor feedback from stakeholders to improve quality assurance processes.
• Adverse Outcomes and Incident Reporting: Support the management of adverse outcomes, including liaising with relevant consultants or clinical teams, and ensure proper reporting and documentation of non-conformance or adverse incidents.
• HFEA Compliance Support: Work alongside the Quality Manager to ensure adherence to HFEA regulations, assisting in maintaining a positive relationship with the HFEA, and contributing to accurate record-keeping and reporting.
• Second-Witness Role: Act as a second witness during the final quality review of donor content prepared for online publication, ensuring all data aligns with policies and procedures.
• Pathology and Genetic Data Review: Assist in reviewing donor pathology and genetic results, ensuring they fall within required frameworks, and communicate any adverse findings promptly to the appropriate teams.