We are looking for a Quality Administrator to help provide essential administrative and coordination support to the Quality & Compliance function, helping to maintain robust document control, records management, and quality tracking across the organisation.
This role will support the effective operation of the Quality Management System (QMS) through day‑to‑day management of quality documentation and logs, coordination of meetings and actions, and timely follow‑up of key quality activities such as CAPAs, non‑conformances and deviations.
The post‑holder will help ensure controlled information is accurate, current, accessible to the right teams, and managed in line with applicable requirements (GCP, GDPR, ISO 9001 and ISO 27001).
Requirements
Main Duties
* Manage the Master Document List and support day‑to‑day document control activities (e.g., upload, version management, access/sharing) across SharePoint, the Document Management System (DMS) and/or (as applicable).
* Prepare controlled documents for electronic signature using Adobe Acrobat, ensuring correct routing, version status and filing of signed records.
* Maintain and update quality logs and trackers (e.g., NC/OFI/Deviation logs; study‑specific logs; CSV‑related logs where required), ensuring completeness, accuracy and appropriate escalation.
* Support CAPA administration by tracking actions, issuing reminders to action owners, escalating overdue actions, and maintaining CAPA status reporting.
* Support internal audits and inspection‑readiness activities, including collation of evidence, scheduling, coordinating attendees, and supporting on‑site requirements where necessary.
* Assist with internal quality reviews to support continuous improvement, including coordinating inputs and tracking agreed actions to closure.
* Support collection, collation and basic interpretation/presentation of quality‑related metrics at company‑wide and project/study level (e.g., incidents, non‑conformances, deviations, data queries and other ad hoc study metrics).
* Organise Quality/Governance meetings (e.g., governance group, quality meetings), including scheduling, agenda support, note taking, and action tracking.
* Support compliance record‑keeping activities such as routine checks of training record completeness and follow‑up where gaps are identified.
* Participate in validation testing of identified systems, as required, including documentation support and evidence collation.
* Review head office temperature monitoring records (where assigned), ensuring excursions are logged, investigated and appropriately escalated; liaise with operational teams as needed.
* Support the Quality team with general administration, including filing, controlled record organisation, and responding to requests for quality documentation from internal stakeholders.
Experience - Essential
* Experience in an administrative, coordination or document control role, ideally within a regulated environment (e.g., clinical research, healthcare, quality, compliance, regulated services).
* Demonstrable ability to manage controlled documents and records with strong attention to detail (version control, filing, traceability, access control).
* Strong IT literacy, including confidence using Microsoft 365 tools and shared repositories (e.g., SharePoint) and learning new systems quickly.
* Ability to manage multiple priorities, maintain trackers/logs accurately, and meet deadlines.
* Strong communication skills, including confident follow‑up with action owners and escalation where required.
Experience - Preferred
* Familiarity with Good Clinical Practice (GCP) and/or working in a GxP environment.
* Awareness of data integrity principles (e.g., ALCOA+) and how they apply to record‑keeping.
* Experience using eQMS/DMS platforms (e.g., Ideagen) and/or electronic signature tools (e.g., DocuSign or Adobe Acrobat).
* Exposure to ISO standards relevant to quality and information security (e.g., ISO 9001, ISO 27001) and/or GDPR requirements.
Key Skills
* High attention to detail and accuracy; able to spot inconsistencies and follow up to resolution.
* Analytical mindset with ability to maintain and interpret basic metrics and trend information.
* Strong organisation and time‑management skills; able to coordinate meetings, actions and documentation efficiently.
* Professional and proactive communication style; able to chase actions and support stakeholders constructively.
* Discretion and integrity when handling confidential information.
Other Requirements
* Ability to work flexibly to support audit/inspection preparation activities, including occasional time‑sensitive requests.
* Willingness to travel occasionally to sites/offices as required to support internal audit activity or quality initiatives.
Benefits
* Bank holidays, plus 25 days annual leave, increasing to 28 after 5 years
* Buy & Sell holidays
* Enhanced Maternity and Paternity leave
* 1 Occasion day each year, this could be your child's first day of school, their nativity play or your own birthday - the choice is yours!
* Healthshield, our healthcare cash plan
* Cycle to work scheme
* Electric car scheme
* Tech scheme
* Wellbeing support from our qualified mental health first aiders
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