Location: Didcot, Oxfordshire, UK
Pay Rate: £13.00 - £18.50 per hour
Schedule: Monday - Friday, Core Business Hours (Occasional Overtime as Required)
Contract: 6 months
Reporting to the Site Compliance Lead, the QA Administrator - Document Control & Training is responsible for supporting GxP documentation, records management, and training administration activities in accordance with business requirements and regulatory expectations. The role will work closely with Global Process Owners and cross-functional stakeholders to ensure effective management of controlled documents, training records, and compliance-related administrative processes.
The successful candidate will oversee both paper-based and electronic document workflows, including document issuance, reconciliation, chain of custody, archival, and training administration, while maintaining compliance with cGMP, GxP, and data integrity requirements.
Document Control & Records Management
- Maintain controlled document listings applicable to the Harwell Resilience site.
- Manage the issuance, maintenance, reconciliation, and control of GxP documentation.
- Create, issue, and reconcile logbooks.
- Perform document scanning, filing, and archiving activities.
- Manage the archival of cGMP documentation both on-site and off-site, including organization and maintenance of the on-site archival room.
- Support document control process improvements, including document types, lifecycles, and workflows within the electronic Document Management System (eDMS).
- Ensure compliance with Good Documentation Practices (GDP) and Data Integrity requirements.
- Support onboarding and training requirement assignments in accordance with role profiles.
- Track and monitor training completion against planned schedules.
- Provide training support and deliver training sessions as required.
- Maintain training records and support training compliance activities.
- Provide document control and records management support during internal and external audits.
- Ensure documentation and records are completed, maintained, and readily available for audits and inspections.
- Monitor and trend Document Control and Training performance metrics.
- Participate in Quality Management Reviews (QMR) as requested.
- Collaborate with cross-functional teams to identify opportunities for process improvements and efficiencies related to document and records management.
- Efficiently manage document control, records management, and training-related activities.
- Support additional administrative duties as required by the business.
Education & Experience
- 3-5 years of experience within the pharmaceutical, biotechnology, life sciences, or a related regulated industry.
- Experience working within current Good Manufacturing Practice (cGMP) environments.
- Demonstrated ability and willingness to develop a strong understanding of GxP regulations and compliance requirements.
- Experience with document control, records management, and training administration processes.
- Familiarity with electronic Document Management Systems (eDMS).
- Understanding of Good Documentation Practices (GDP) and Data Integrity principles.
- Proficiency in Microsoft Office applications.
- Strong attention to detail and organizational skills.
- Ability to manage multiple priorities while maintaining compliance and accuracy.
- Strong written and verbal communication skills.
- Ability to work collaboratively across cross-functional teams.
- Continuous improvement mindset with the ability to identify process efficiencies.
- Strong record-keeping and administrative capabilities.
- Ability to work independently and within a team environment.
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