Analyst R&D Technical Writing

Title: Analyst, R&D Technical Writing

Location: Fremont, CA

Managers note:

• Technical writing background, familiarity with INDesign, Illustartor, Word.
• Someone who has experience with SOP, IFU Procedure writing
• Quality background and who has worked around technical writing
• Ideal candidate would be someone who has labeling, medical device labeling, food labeling, understanding what compliance is and why the details are so important having some regulatory/Quality background is a big thing.

Job Description:

• Analyst, R&D Technical Writing, as a part of Packaging R&D, is responsible for creating end-user regulatory complaint product labeling that will support business requirements.
• The specialist may contribute to new product development and design change (sustaining) activities in the areas of label design/release, development of artwork/images and development or improvement of processes for improved efficiency and compliance.
• This role will engage with and mobilize cross functional teams to resolve obstacles effectively, be responsible for meeting key labeling objectives, and lead/collaborate on continuous improvement initiatives or special activities having business impact.

General Requirements:

• 2-4 years of relevant experience
• Bachelor’s Degree in Graphics or Language or equivalent experience (Advanced degree may be considered towards years of experience)
• Be required to have a high level of service and responsibility in managing a high and varied workload from internal customers and be comfortable working to tight timelines
• Provide weekly summary of activities, create project plans, prioritize, and effectively communicate updates to customers
• Follow Good Document practices (GDP) for all documentation created/reviewed and staying current on all required training for incumbent position

Qualifications/Work Experience Required:

• Microsoft applications (Word, Excel, PowerPoint, and Visio)
• Adobe Suite (InDesign, Photoshop, and Illustrator)
• Demonstrated application using database driven labeling system such as Prisym ID, Label View, Loftware, Bartender, Nice Label, and/or Easy Label.
• Support IFU development and release in PLM for new product development and design changes in conjunction with product labeling to ensure congruency with strong attention to detail
• Manages tasks related to IFU/ Literature printing suppliers and translation supplier Essential

Duties & Responsibilities:

• Researches and builds knowledge about products, service, technology, test method and documents in the clearest, most logical way for greatest reader comprehension
• Drives continuous improvement (NCs and CAPAs) and assessment of current procedures, generation of quality plans and identification of best practices
• Prepare for internal and external audits by gathering records, supporting backroom, and providing explanation for design areas developed by self with auditor in the Front Room
• Fully support the Quality Policy by building quality into all aspects by maintaining compliance to all quality requirements and supporting improvements that make it easier for the organization to maintain compliance in complex areas
• Demonstrated extensive application of knowledge through delivery of high-quality deliverables (SOPs, technical literature and Work Instructions, engineering work product) to ensure continuity of content style that meets applicable standards and is appropriate for its intended audience
• Strong attention to detail, reviews and audits other technical publications deliverables and consistently delivers quality documentation with no escapes

Additional Job Details:

• As regulations change and quality systems are merged/aligned, execute the creation/refinement of department and quality system SOPs, Work Instructions, forms, and templates that have considerable graphical content with minimal supervision
• Provides input to creation of training and communication materials that can be used by self or other staff to convey new or updated processes
• Experienced in modifying existing and creating new Quality System documentation (work instructions, standing operating procedures, forms, checklists, and templates)
• Lead structured problem-solving initiatives to resolve complex technical issues and document within appropriate quality system documentation