Quality Officer

at  Source BioScience

Company Description
Source BioScience is an international genetic analysis, diagnostics and stability storage business serving the global research and healthcare markets. We pride ourselves on maintaining a friendly working culture that gives driven individuals the environment to succeed in an evolving and developing organisation.
Job Description
The role has responsibility for the day-to-day management of the quality system at the Nottingham site, as well as supporting wider operation of quality across other sites within the business and will be critical for driving continual improvement across the company via feedback from the management system.
This role will support the Head of Diagnostics Development & Quality in the ongoing delivery of quality management, maintaining ISO 15189 and ISO 9001 accreditation and ensuring regulatory compliance with CQC, MHRA, HTA and other regulators.
You will have a high level of responsibility to ensure the successful delivery of pathology services, through an effective management that meets the needs of users, in line with our company vision and quality objectives.
Source BioScience has locations in Nottingham, Cambridge and Chichester, providing diagnostic healthcare services (cellular pathology and molecular diagnostics) and genomics services to industry and academia. The position is based at the Orchard Place site in Nottingham but may require visits to other sites in the business as and when required (e.g., performing audits).
Duties include:

Day to day management of the quality system across the business and supporting implementation of the management system at Orchard Place, consisting of:

• Performing audits of the management system, managing the audit schedule and making sure this is complete on time.
• Management of the Q-Pulse eQMS system including:
• Workflow module (incident reporting/CAPA).
• Audit Module
• Document module
• Customer & Supplier modules
• Asset modules
• Administration
• Writing, and review of quality policies, SOPs and documents.
• Quality review and approval of documents across the business and ensuring appropriate document control is implemented.
• Process improvement and incident & complaint management.
• Incident investigation and root cause analysis, including supporting other departments in the business to complete investigations appropriately, ensuring corrective and preventive actions are effective.
• Support the Clinical Risk Management process through integration into the management system and management of risk assessments and failure modes effects analysis.
• Assist in collating data and preparing the Annual Management Review (AMR) and monthly quality reports.
• Assist in producing monthly quality reports, reporting on KPIs and quality objectives
• Supporting the business in achieving quality objectives – ensuring these are set, monitored and actioned.
• Co-ordinating the internal awareness of the needs and requirements of the users through the management review, user feedback, assessment and audit feedback, complaints, incidents and KPI monitoring/quality objectives.
• Provide training for staff undertaking quality related activities, as required. (e.g., training in performing audits and root cause investigation.
• Supporting quality leads at other sites within the business, with occasional travel if necessary (such as performing audits).
• Supporting the development team to new introduce new methods and equipment and maintain the validation status of methods and equipment throughout the business, and ensuring this is completed in accordance with the management system.
• Supporting development and continual improvement of the management system
• Deliver the expectation of the service users whilst also balancing the interests of the company.
• To lead by example, demonstrating professionalism to colleagues commensurate with post.
• To comply with safe working practises in accordance with Company safety policies
• To participate in the Annual Joint Staff Review process, in accordance with Company Policy.
• To perform any other duties as may be reasonably required commensurate with grade and experience.
• Attend any training endeavours as appropriate to the role or as reasonably requested by Line Manager.

Qualifications

Minimum requirements:

• Experience of operating management systems within a regulated environment.
• 3 years’ experience in either ISO 15189, ISO 9001 or ISO 17025 accredited environments.
• Training/education in quality management
• Auditing experience
• Experience and understanding of root cause analysis

Desirable:

• Experience of management of quality systems to ISO 15189 standards.
• Experience of cellular pathology, molecular techniques, sequencing and genomics.
• Familiarity with Q-Pulse
• Experience in risk management, ISO 27001 or DCB 0129/0160

Additional Information

SALARY £35,000 TO £40,000 DEPENDING ON EXPERIENCE.

• Income Protection
• Life Assurance x4 salary
• Employee Assistance Programme
• Medicash health cash plan
• Shopping & leisure discount portal
• Virtual GP Service
• mProve Yourself health and wellbeing resources
• SkinVision App
• Able Futures Mental Health support
• 33 days holiday (inclusive of bank holidays) increasing with LOS
• An extra day off on your birthday
• Option to buy and sell holidays
• Cycle to work scheme

Please refer the Job description for details