Document Control Specialist III

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries and in more than 100 territories through distributors.

Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

The Document Control Specialist III guides, executes, and improves Document Control processes including document changes, quality records control, labeling creation, SAP master data entry, and training record maintenance activities. This role ensures compliance with organizational standards and regulatory requirements and improves the efficiency and quality of Document Control processes.

• Document and Data Processing and Entry – Initiate and process change orders, review verbiage and content for errors, ensure standardized formats and file naming conventions, confirm appropriate approvers, communicate with stakeholders, monitor aging change orders, and coordinate periodic review.
• Document and Record Lifecycle Management – Optimize processes for creation, acceptance, review, storage, distribution, and archiving of controlled documents and records.
• Department Procedures – Create and revise SOPs, work instructions, checklists, forms, and templates for document and record lifecycle management, training, and product labeling; maintain accuracy and compliance.
• Process Improvement – Lead and implement process improvements for accuracy, efficiency, effectiveness, and cycle times; represent Document Control in cross‑functional projects.
• Training & Support – Serve as SME for training on Document Control activities; develop, deliver, and maintain training materials; train new team members and support training sessions.
• Metrics & Reporting – Maintain tracking data, reporting documents, labeling, and training metrics; analyze and respond to trends.
• Product Labeling – Optimize processes for creation, review, maintenance, and archiving of product labeling; print restricted product labeling.
• Quality Records Management – Scan, file, archive, and dispose of paper and electronic quality records per required retention periods.
• Audit Support – Support internal and external audits and regulatory inspections; pull requested documents, respond to queries, and represent Document Control.
• Compliance – Follow applicable Werfen SOPs, national and international regulations, ISO standards, EHS, HR, and other relevant policies.
• Other Duties – Perform additional responsibilities as assigned; embody Werfen values and align daily actions with department goals and company culture.

• Quality Teams
• Regulatory Teams
• Manufacturing Teams
• Operations Teams
• Marketing Teams
• Supply Chain Teams
• Legal & Human Resources
• Research and Development Teams

Minimum Education: Bachelor’s degree in a relevant field (e.g., Life Sciences) or equivalent experience.

Minimum Experience: 7+ years of document control experience in vitro diagnostics or medical devices.

• Advanced knowledge of document lifecycle management and maintaining documents within quality system requirements.
• Advanced knowledge of ISO 13485 and related QMS standards.
• Advanced knowledge of GDP and GRP.
• Advanced experience drafting, updating, and implementing SOPs, work instructions, forms, and templates.
• Advanced experience configuring document control and lifecycle management within a regulated QMS.
• Advanced experience with SAP for document control and material master management.
• Experience leading departmental projects and representing in interdepartmental projects.
• Experience with quality‑related training systems.
• Experience with ERP, eDMS, LMS, and other computerized information systems.
• Proficient in Microsoft Office Suite.

• Attention to Detail & Accuracy
• Organization & Time Management
• Communication (written and verbal in English)
• Collaboration &…