Company Description
Source BioScience, comprised of Source LDPath and Source Genomics, provides industry-leading laboratory services in genomics, multiomics and healthcare diagnostics, partnering with biotechnology, pharmaceutical, healthcare and academia. For more information, please visit www.sourcebioscience.com.
Job Description
The role has responsibility for the day-to-day management of the quality management system within Source BioScience, as well as supporting operation of quality across the healthcare 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, other relevant standards and ensuring regulatory compliance with CQC, MHRA, HTA and any other relevant regulators.
You will have a high level of responsibility to ensure the successful delivery of pathology services through 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. The role will require infrequent 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, consisting of:
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Performing audits of the management system, managing the audit schedule and making sure this is complete on time.
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Management of the eQMS system including:
- Workflow module (incident reporting/CAPA).
- Audit Module
- Document module
- Customer & Supplier modules
- Asset modules
- Administration
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Process improvement and incident & complaint management.
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Incident investigation and root cause analysis, including supporting other departments in the business to complete investigations appropriately, ensuring corrective and preventive actions are effective.
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Writing, and review of quality policies, SOPs and documents.
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Quality review and approval of documents across the business and ensuring appropriate document control is implemented.
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Ensuring the validation and verification policy is adhered to, ensuring there is a process in place for performing equipment, procedures, methods and software validations/verifications and maintaining in a validated state.
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Support the Clinical Risk Management process through integration into the management system and management of risk assessments and failure modes effects analysis.
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Preparing the Annual Management Review (AMR) and monthly quality reports.
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Produce monthly quality reports, reporting on KPIs and quality objectives.
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Supporting the business in achieving quality objectives – ensuring these are set, monitored and actioned.
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Co-ordinating the internal awareness of the needs and requirements of the users through the AMR, assessment and audit feedback, complaints, incidents and KPI/quality objectives.
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Provide training for staff undertaking quality related activities, as required. (e.g., training in performing audits and root cause investigation).
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Liaise with, lead and support accreditation and certification assessment visits and responses.
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Support any third-party audits by regulators or clients.
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Supporting quality leads within departments and at other sites within the business, with occasional travel if necessary (such as performing audits).
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Provide training for quality leads and any other staff undertaking quality related activities, as required.
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Deliver the expectation of the service users whilst also balancing the interests of the company.
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To lead by example, demonstrating professionalism to colleagues commensurate with post.
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To comply with safe working practises in accordance with Company safety policies
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To participate in the Annual Joint Staff Review process, in accordance with Company Policy.
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To perform any other duties as may be reasonably required commensurate with grade and experience.
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Attend any training endeavours as appropriate to the role or as reasonably requested by Line Manager.
Qualifications
Minimum requirements:
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Experience of operating and being responsible for management systems within pathology laboratories to ISO 15189 standards.
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Minimum 3 years’ experience in either ISO 15189, ISO 9001 or ISO 17025 accredited environments.
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Auditing experience
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Experience and understanding of root cause analysis
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HCPC registered Biomedical Scientist status
Desirable:
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Qualification in quality management
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Experience of cellular pathology, molecular techniques, sequencing and genomics.
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Experience with GCP/clinical trials
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Familiarity with Q-Pulse
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Experience in risk management, ISO 27001 or DCB 0129/0160
Additional Information
Company Benefits include:
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Pension
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Income Protection
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Death in Service
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Employee Assistance Programme
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Medicash health cash plan
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Shopping & leisure discount portal
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Virtual GP Service
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mProve Yourself health and wellbeing resources
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SkinVision App
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Able Futures Mental Health support
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33 days holiday (inclusive of bank holidays)
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An extra day off on your birthday
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Cycle to work scheme
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Discounted private healthcare
Due to the volume of applications, we apologise that we are unable to respond individually to each application. If we have not contacted you within 7 working days your application has been unsuccessful and your details have not been retained. Please feel free to apply for any other position you may see in the future.
