GMP Technical Document Editor

GRIFOLS, S.A. • San Diego, CA

2d • $73,424 - $91,780 • Onsite

About The Position

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.

Requirements

• 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 proficiency in editing and proof-reading technical documents, with excellent grammar, punctuation, and clarity
• Working knowledge with electronic document management systems (eDMS) such as Documentum, LSQM, MasterControl, and document control software
• Working knowledge of MRP and/or ERP systems such as SAP, Axapta, Microsoft Dynamics
• Excellent organizational skills and attention to detail
• Strong communication skills with the ability to collaborate effectively with cross-functional teams and stakeholders
• Working knowledge of quality management systems (QMS) and audit processes
• Understanding of Change Request processes (ECRs, ECOs) for material management impacted by document control changes
• Excellent written and oral communication, and editorial skills
• Strong interpersonal skills; ability to learn new concepts quickly and manage multiple projects at once; comfortable with shifting priorities and schedules
• Understanding of regulatory requirements for medical device documentation (e.g., FDA 21 CFR Part 820, ISO 13485)
• Bachelors degree in a relevant field or equivalency is required
• Minimum of 2 years experience in editing technical documentation
• 6+ years of direct experience in lieu of education and experience, preferably in the medical device or pharmaceutical industry

Nice To Haves

• Proficiency in Madcap Flare is a plus

Responsibilities

• 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

Benefits

• Medical
• Dental
• Vision
• PTO
• up to 5% 401(K) match
• tuition reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 101-250 employees