Company Site
QC Document Controller
Argenta
Dundee, GBR
Mid
Onsite
Discovered 6 days ago
Communication
Role Overview
The QC Document Controller will be responsible to own and maintain the QC document control system, ensuring SOPs, analytical methods, specifications, protocols, controlled records and training records are accurate, current, traceable and compliant with GMP and Data Integrity requirements.
The role enables the QC laboratory to work right first time and remain inspection-ready, provides a reliable point of contact for document queries and supports continuous improvement.
Key Skills for This Role
Communication
Full Job Posting
Experience
- Pharmaceutical, laboratory or related environment awareness
- HNC or Degree in relevant scientific Discipline (e.g. Chemistry/Pharmacy/Biology)
- Experience of document control within a GMP-regulated environment, ideally a pharmaceutical QC laboratory.
- Strong knowledge of GMP, Good Documentation Practice and Data Integrity (ALCOA+) requirements.
- Experience of using electronic document management and quality management systems.
- Understanding of change control, CAPA, deviation and training processes.
- Excellent attention to detail and accuracy.
- Strong organisational skills, with the ability to prioritise and meet deadlines in a changing environment.
- Good written and verbal communication skills, with the ability to work with colleagues at all levels.
- Ability to work independently, as well as part of a team across different functions, and to lead and guide team members.
- Follow Health and Safety practices and policies by reporting incidents and hazards and promote safe working in the QC area.
- Ensure QC documentation meets GMP, Good Documentation Practice and Data Integrity requirements, and escalate situations where quality is compromised.
- Manage the lifecycle of QC SOPs and analytical methods, including formatting, review routing, approval, issue, periodic review and withdrawal.
- Maintain controlled specifications, test methods, and validation and stability protocols and reports, ensuring version control and traceability.
- Issue, track and reconcile controlled logbooks, worksheets and templates, and check that completed records are complete and filed.
- Manage the archiving, retention and retrieval of QC records in line with retention requirements.
- Maintain training records and assign document-related training when documents are issued or revised, tracking completion with managers and team leads.
- Support change control, CAPA and deviation actions relating to documentation, and track closure of document-related actions.
- Provide document control reporting (e.g. documents in workflow, overdue reviews) and support regulatory and client audits by retrieving and presenting records.
- Administer and use electronic document management and quality systems, support users and escalate system issues.
- Act as the point of contact for QC document queries, coach colleagues on document control requirements, and identify improvements that make document processes simpler and more efficient.
Key Responsibilities
- Follow Health and Safety practices and policies by reporting incidents and hazards and promote safe working in the QC area.
- Ensure QC documentation meets GMP, Good Documentation Practice and Data Integrity requirements, and escalate situations where quality is compromised.
- Manage the lifecycle of QC SOPs and analytical methods, including formatting, review routing, approval, issue, periodic review and withdrawal.
- Maintain controlled specifications, test methods, and validation and stability protocols and reports, ensuring version control and traceability.
- Issue, track and reconcile controlled logbooks, worksheets and templates, and check that completed records are complete and filed.
- Manage the archiving, retention and retrieval of QC records in line with retention requirements.
- Maintain training records and assign document-related training when documents are issued or revised, tracking completion with managers and team leads.
- Support change control, CAPA and deviation actions relating to documentation, and track closure of document-related actions.
- Provide document control reporting (e.g. documents in workflow, overdue reviews) and support regulatory and client audits by retrieving and presenting records.
- Administer and use electronic document management and quality systems, support users and escalate system issues.
- Act as the point of contact for QC document queries, coach colleagues on document control requirements, and identify improvements that make document processes simpler and more efficient.
About Argenta
Pharmaceutical Manufacturing1000 employeesFounded 2006
Global animal-health CRO/CDMO providing research, regulatory, product-development, and manufacturing services to animal-health companies.
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