Documentation Specialist

Documentation Specialist - Contract

The Documentation Specialist is responsible for the coordination, execution, and maintenance of manufacturing documentation in a cGMP-regulated environment. This role ensures the timely progression of documents through all lifecycle stages and supports production, inventory, and quality compliance activities through accurate and efficient document control processes.


Key Responsibilities:

• Coordinate internal and external review and approval of manufacturing documents.
• Ensure documentation progresses in line with site policies, cGMP, and GDP requirements.
• Act as the main point of contact for documentation processes within manufacturing.
• Manage the flow of documents in and out of ABB documentation systems.
• Support new product introduction (NPI), technology transfers (TT), and routine manufacturing through documentation readiness.
• Revise, update, and format manufacturing documentation including MBRs, SOPs, forms, logbooks, and label templates.
• Ensure alignment between batch records and executed processes.
• Investigate documentation-related issues with quality/compliance impact and document outcomes.
• Track operations/business metrics and report on schedule adherence and manufacturing KPIs.
• Provide training and guidance on new or updated documentation.
• Support inventory management and production documentation in SAP.
• Interface with planning and procurement to support batch and purchase order management.
• Maintain accurate records and ensure efficient execution of documentation across all manufacturing stages.

Qualifications & Requirements:

• Bachelor’s Degree (Science or related field preferred) or equivalent experience.
• Minimum 1 year of experience in document control/records management in a regulated industry.
• Experience in a GMP manufacturing environment strongly preferred.
• Proficient in Microsoft Office Suite (Word, Outlook, Excel, PowerPoint, Visio).
• Expert in formatting, proofing, and editing GMP documentation for compliance.
• Familiarity with electronic document management systems.
• Demonstrated ability to manage documentation timelines in a fast-paced, deadline-driven environment.
• Knowledge of SAP for inventory and production documentation is highly advantageous.

For a confidential conversation about the role 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