Laboratory Quality Specialist (Onsite Oxford)

Location: Full time on site in our Oxfordshire site (Kidlington) UK. Travel to other UK office in Exeter & other non UK locations as required.

Right to Work: Candidates must be based in and have the right to work in UK. We are unable to offer UK visa sponsorship for this UK based role.

About this Role: This role is for a Laboratory Quality Specialist, an experienced scientific and technical professional who has a good understanding of accredited histopathology laboratory operations both in the context of clinical trials and digital clinical laboratory and reporting services. This role is centered on proactively improving quality processes by preventing errors, defects, and operational inefficiencies within laboratory workflows. It involves establishing and monitoring quality metrics across laboratory processes, analysing quality data, and leading root cause investigations and continuous improvement initiatives to enhance overall laboratory performance. In addition, this role will have responsibility for implementing, overseeing and promoting the laboratory quality management system in their area.

You will be successful in this role if you are proactive in taking initiative, adept in engaging diverse stakeholders, innovative with problem-solving, and have a collaborative spirit within a team environment.

Responsibilities:

• Quality role to support digital scanning and histopathology laboratory operations in the UK.
• Lead and coordinate data driven quality improvement initiatives by overseeing data monitoring, conducting root cause analysis, and developing improvement plans, while driving effective change management within the quality management system.
• Evaluate and streamline existing end to end processes and procedures from customer onboarding to post delivery of services.
• Support automation and reduction of manual processes using technology.
• Oversee document control within the laboratory; ensure documents are reviewed and streamlined in a timely manner; and that all documents issued are correctly controlled & managed in line with the document control procedure.
• Develop and implement laboratory policies and procedures to ISO 15189:2022, GLP and IHC GCP requirements ensuring quality and integrity of laboratory data.
• Maintain UKAS accreditation for laboratory operations and services to ISO 15189:2022, ensuring compliance to these.
• Oversee the audit calendar for the laboratory; ensuring all internal and supplier audits are carried out in a timely manner, in liaison with the Operations Manager.
• Conduct and monitor laboratory audit non-conformance, CAPAs and error logs; liaise with the Operations Manager to ensure that actions are appropriately delegated and closed within the required timeframe.
• Compile error log reports on a monthly basis & provide monthly trend analysis for KPI reviews.
• Work closely with managers in providing advice and support to staff in the implementation of the quality management system, particularly in regards to documentation, training, audit and non-conformance management.
• Act as the point of contact for the Quality Manager within the laboratory, and ensure that any relevant instructions and information from the Quality Manager are disseminated.
• Ensure that all employees are aware of their responsibilities with regards to quality management; are adequately trained; and that all staff performing quality tasks have completed relevant competencies for performing such tasks.
• Manage participation in the EQA schemes that the laboratory subscribes to, on behalf of the Operations Managers.
• Liaise regularly with the Operations Manager on quality management issues, identify areas of concern and take action where necessary.
• Share learning and good practice with the other services within the company.
• Work with the Operations Manager in the provision and collation of evidence for UKAS.
• Assist the Quality manager with closing non-conformities and implementing corrective actions.
• Co-ordinate regulatory audits of laboratory services as required, for example UKAS, MHRA.
• Support the development and implementation of AI-assisted pathology tools for clinical and preclinical use, ensuring regulatory acceptance as applicable.
• Support any other duties as assigned by quality management.
• Periodic international travelling will be required to company sites, up to 10% travel will be required.
• Training required for the role may include ISMS, GLP, DocuSign and GDPR/HIPAA awareness.

Required Skills and Experience:

• Bachelor's degree in Biomedical Science or similar Life Science qualification.
• At least 5 years of experience in ISO 15189 accredited histopathology laboratories.
• Experience with digital pathology.
• Excellent communication, collaboration, and leadership skills.
• Strong problem-solving and analytical skills.
• Ability to work under pressure and meet tight deadlines.
• Experience and certification with process improvement methodologies is a distinct advantage.
• Experience with Generative AI tools and technology is a distinct advantage.
• Knowledge of AI cloud computing, electronic data archiving is an advantage.

You will have shown leadership skills in previous positions and are keen to develop these skills further by owning your role from end to end. You bring a sense of urgency to the work that you do and are able to execute on tasks by using your initiative. You enjoy innovating and bringing new ideas to the table. You like to have autonomy in your role and the independence to manage your own time and workload. You are highly collaborative and enjoy working with lots of different teams and people. You thrive in a fast paced environment and can manage changing priorities. You have great written and oral English language skills.

About the Company: Diagnexia, a subsidiary of Deciphex: Accelerating Certainty and Pioneering Pathology Services. Diagnexia, a leading provider of pathology services, operates as a subsidiary of the parent company, Deciphex. Established in Dublin in 2017, Deciphex has rapidly expanded to become a global team of over 230 professionals, offering innovative software solutions to address the pathology gap in both research and clinical areas. With a mission to accelerate the drug development process and provide timely, accurate diagnoses for cancer patients, Deciphex has established a strong presence through its offices in Dublin, Exeter, Oxford and Chicago. As part of the Deciphex family, Diagnexia leverages its expertise to provide cutting-edge diagnostic solutions to healthcare organizations worldwide. Our cloud-based platform enables hospitals to easily and rapidly send cases for a consultation to our team of expert subspecialists. We are dedicated to improving patient outcomes and helping healthcare organisations stay at the forefront of the industry. We are software developers, clinical specialists, AI engineers, operations professionals and so much more, all working as one team to support our customers and patients. Our team culture is built on trust. We give our team the space they need to deliver results and the environment to ensure they can enjoy doing it. We are looking for a highly motivated individual who is excited to take on challenges and value making a difference in their day-to-day work. This is a unique opportunity to make a difference in the emerging Digital Pathology field.

What are the benefits of working with Diagnexia?

• Competitive salary.
• Healthcare benefits.
• Competitive annual leave.
• A true sense of meaning in your work by contributing to better patient outcomes.
• The opportunity to work alongside a world-class high performing team in a hyper-growth startup environment.
• A chance to work on exciting, challenging and unique projects.
• Regular performance feedback and significant career growth opportunities.
• A highly collaborative and supportive multi-cultural team.

Deciphex is an equal opportunities employer and we are committed to the principle of equality. All qualified applicants will be considered for employment without regard to age, race, religious beliefs, political views, gender identity, affectional or sexual orientation, national origin, family or marital status (including pregnancy), disability, membership of the travelling community or any other classification protected by applicable law.