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Grifols · 23 hours ago

Technical Document Editor

SD Metro Area

Full-time

Onsite

Entry, Mid Level

$73K/yr - $92K/yr

2+ years exp

Grifols is a global healthcare company that has been working to improve health and well-being since 1909. They are seeking a Technical Document Editor to support their Labeling Team by managing technical documentation and ensuring compliance with regulatory standards.

BiotechnologyHealth CareManufacturing

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

Qualification

Adobe FrameMakerTechnical Document EditingEDMSMicrosoft OfficeSAPQuality Management SystemsProofreadingProject ManagementInterpersonal SkillsCommunication SkillsAttention to Detail

Required

Bachelors degree in a relevant field or equivalency is required

Minimum of 2 years experience in editing technical documentation

Advanced proficiency in document authoring and publishing tools such as Adobe FrameMaker

Experience must be current and used in a professional setting

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)