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Documentation Specialist
Industry specialist
Owen Clancy
Recruitment Consultant
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Competitive
Contract
Documentation Specialist (Laboratory)
We are seeking a detail-oriented Documentation Specialist to support laboratory operations in a regulated environment. This role is critical in ensuring documentation meets GMP/GDP compliance and is delivered on time to support manufacturing and quality objectives.
Key Responsibilities:
Requirements:
For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose
We are seeking a detail-oriented Documentation Specialist to support laboratory operations in a regulated environment. This role is critical in ensuring documentation meets GMP/GDP compliance and is delivered on time to support manufacturing and quality objectives.
Key Responsibilities:
- Coordinate review and approval of laboratory documentation (SOPs, logbooks, forms)
- Ensure documents progress efficiently through approval workflows in line with timelines
- Maintain and manage documentation within electronic systems
- Act as a key point of contact for document status and process queries
- Support laboratory readiness for NPI, Tech Transfer, and routine manufacturing
- Review, edit, and format documents to ensure accuracy and compliance (GMP/GDP)
- Track and report on documentation metrics and performance
- Participate in investigations, root cause analysis, and continuous improvement initiatives
- Collaborate cross-functionally to ensure consistency and compliance
Requirements:
- Bachelor’s degree (preferably in Science or related field)
- 1 year experience in a regulated laboratory or document control environment
- Strong knowledge of GMP/GDP standards
- Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, Visio
- Experience with electronic document management systems preferred
- Excellent attention to detail, organisation, and communication skills
- Ability to work in a fast-paced, deadline-driven environment
For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose
