QA Co-ordinator

The QA Co-ordinator will support the Quality Manager in the coordination and delivery of quality operations (both Histology and In-vitro Biology), to ensure that the team fulfil their legal obligations as expected of a contract research organisation delivering clinical trial sample analysis services to good clinical laboratory practise (GCLP) standards ensuring compliance with statutory requirements as well as internal quality policies.

Under the direction of the Quality Manager, the QA Coordinator will implement, maintain and develop (where appropriate) the promotion and enforcement of stringent quality systems for GCLP research processes that safeguards patient welfare, ensures the validity of data produced, protects research staff and minimises organisational risk.

The QA Co-ordinator will support the Quality Manager in the coordination and preparation for regulatory inspections by external agencies e. the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Responsibilities:

- Maintenance of the company SOP system and implementation of systems to ensure review and compliance.
- Ensure quality tasks are assigned to team members and provide support for completion.
- Ensure that appropriate staff training and development is in place to assure competency in role to achieve objectives and that records are up to date and maintained.
- To be supportive in establishing relevant Computer System Validation (CSV) processes and documentation.
- To implement GCLP standards across the organisation for clinical trial sample analysis.
- Manage/participate in self inspection and audit programme as well as any external (eg. MHRA/other regulatory bodies') audits and actions.
- To investigate any quality issue (eg. deviations, complaints, incidents, OOS) and implement any corrective and preventive action.
- Support the Quality Manager with the introduction and measurement of Key Performance Indicators (KPIs) for quality related measures.
- Maintenance of awareness of any changes in regulatory requirements/guidelines and updates and communicate to the Quality Manager.
- Ensuring appropriate archiving procedures are adopted across the organisation, including the archiving of large data files (images and flow cytometry data).

Knowledge & Skills Required:

- Graduate/Post graduate standard or equivalent in a Science based discipline.
- Relevant Quality Assurance training.
- Proven experience of developing and implementing quality assurance procedures in a clinical research environment would be advantageous.
- A minimum of 2 years' experience in a QA role.
- Thorough understanding and training in Quality Assurance activities GLP/GCP/GCLP Procedures.
- Excellent eye for detail and accuracy in recording and reporting information.
- Ability to excel in a dynamic, fast-paced work environment
- Excellent verbal/written communication and interpersonal skills
- Competent computer skills (Microsoft Office, Excel etc.) Ability to embrace change and to drive forward QA objectives.