Document Control Specialist (3523)

Utilizing proofreading and editing skills, supports Jr. and Sr. Technical Communicators with organization, review, and maintenance of technical labeling materials for medical devices. Candidates must have strong attention to detail, be proficient in understanding and following standard operating procedures and compliance methodology, and complete tasks associated with the editorial review, processing, monitoring, and release of labeling documentation under general supervision.
ESSENTIAL DUTIES AND Responsibilities:
o Review layout, selected content, images, and references in translated operator manuals and labeling training materials against English Master counterpart oReview and align documents to labeling standards and print specifications, including review of barcodes, color separations, bleeds, cross-references, format, and layout oFollow standard operating procedures to ensure documents are accurate and compliant oCommunicate with cross-functional teams to review statuses and identify/resolve issues Other duties and Responsibilities: oAssign part numbers for documents and maintain labeling database throughout labeling process oCreate labeling print specifications and redlines to maintain traceability oManage and track routing and approvals of labeling documentation oUpdate project statuses in Access Database oPerform Quality Checks and release documents into client Quality Management System (QMS)
To perform this job successfully, an individual must possess the following: oStrong, methodical cross-checking abilities (term alignment, document alignment, style alignment) oExcellent attention to detail including ability to identify inconsistencies, errors, and able to match redlines to final artwork oAbility to clearly write, review, and edit documents applying universal grammatical and editorial rules. oEffective communication, interpersonal and conflict resolution skills oExperience with regulated document control or electronic Document Management Systems. oAbility to effectively interpret, follow, and adhere to SOPs, GDPs, and work instructions oAbility to measure, print and review oProficiency in Adobe Acrobat (especially annotations), MS Office
oAbility to work efficiently and effectively in a fast-paced team environment oAbility to organize workload and prioritize multiple projects and tasks oExperience with editing and/or review of scientific content is preferred Additionally, it is imperative that candidates possess the following skillsets: oAbility to work with a sense of urgency on a consistent basis & understand the importance of your contribution to overall success of project. oAbility to quickly adapt to changing project priorities. oAbility to maintain a positive attitude, and handle ambiguity & uncertainty.
High school or equivalent. Some college preferred Two or more years working in a regulated industry

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