Technical Document Editor - Document Control

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Grifols Diagnostic Solutions Inc is seeking a Technical Document Editor to help support our Labeling Team in San Diego, CA. This position will provide formatting and maintenance of technical documentation in support of instrument and software operator manuals, package inserts, SOPs, specifications and training materials.

 

We are seeing individuals with at least a Bachelors degree in a relevant field or equivalency and minimum of 2 years of experience in editing technical documentation and advance proficiency in Adobe FrameMaker. Madcap Flare experience is a plus.

 

Primary responsibilities for role:                                                                    

• Manages labeling change requests, creates and implements templates, style guides, and documentation standards to ensure consistency and quality across all technical documentation, submits finalized documentation for review and approval from internal departments         
• Execute on project management tracking and priorities by keeping internal trackers and databases up to date, partnering with stakeholders to provide and maintain accurate data, ensuring deadlines and deliverables are met on time
• Identify and inform areas for improvement to Labeling processes, styles, formats, and participate/support in execution of continuous improvement initiatives as appropriate
• Liaise with external vendors for submission of translation projects and perform translation reviews of received documentation for consistency in format and layout
• Edit and maintain technical documentation including operator manuals, package inserts, and regulatory submission documents in compliance with regulatory requirements and company standards    
• Edit documents to support Labeling Development in compliance with ISO, cGMP, EU MDR and FDA guidelines, working within established formats and templates
• Represent Labeling Development on Core Teams and collaborate closely with cross-functional teams including Regulatory Affairs, Marketing, Research & Development Instruments, Product Support and Quality Assurance to understand project requirements and ensure alignment on editing timelines
• Revise documentation as requested by stakeholders
• Manage documentation, including version control, review and approvals process, generating clean and redlined drafts in accordance with established procedures
• Manage the creation, review, approval, distribution, and archival of all controlled documents within Labeling Development, including label and packaging artwork and drawings, package inserts, operator's manuals, work instructions, SOPs, forms, and quality records
• Maintain document repositories and electronic document management systems (eDMS), ensuring accurate document metadata, version control, and document history
• Collaborate in-person with cross-functional departments to mitigate operational constraints (batch record discrepancies, GDP errors etc.)
• Assist in-person demonstrations related to content of technical documents, especially for instrument and software documentation             
• Commercial printing of labels and IFUs as required
• Organize and maintain department files, databases and spreadsheets
• Support and execute on Change Control processes in a timely manner
• Support on-site audits and inspections by providing documentation as required
• Stay informed about industry trends, best practices and regulatory updates related to technical editing and apply knowledge to continuous improvement initiatives

                                                         

Knowledge, Skills, and Abilities           

• Advanced proficiency in document authoring and publishing tools such as Adobe FrameMaker.
• Experience must be current and used in a professional setting. Proficiency in Madcap Flare is a plus
• Strong proficiency in Microsoft Office applications, particularly Word, Excel, and SharePoint
• Strong proficien