Comrise
Base pay range
$35.00/hr - $43.00/hr
Role Analyst, R&D Technical Writing, as part of Packaging R&D, is responsible for creating end-user regulatory compliant 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 engages with and mobilizes cross‑functional teams to resolve obstacles effectively, meets key labeling objectives, and leads/collaborates 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)
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 stay current on all required training for the 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 methods 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
Prepares for internal and external audits by gathering records, supporting back‑room, and providing explanation for design areas developed by self with auditor in the front room
Fully supports 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
Demonstrates 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
Shows strong attention to detail, reviews and audits other technical publications deliverables and consistently delivers quality documentation with no escapes
As regulations change and quality systems are merged/aligned, executes 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)
Leads structured problem‑solving initiatives to resolve complex technical issues and documents within appropriate quality system documentation
Seniority level Mid‑Senior level
Employment type Contract
Job function Writing/Editing
Industries Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Aviation and Aerospace Component Manufacturing
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Role Analyst, R&D Technical Writing, as part of Packaging R&D, is responsible for creating end-user regulatory compliant 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 engages with and mobilizes cross‑functional teams to resolve obstacles effectively, meets key labeling objectives, and leads/collaborates 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)
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 stay current on all required training for the 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 methods 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
Prepares for internal and external audits by gathering records, supporting back‑room, and providing explanation for design areas developed by self with auditor in the front room
Fully supports 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
Demonstrates 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
Shows strong attention to detail, reviews and audits other technical publications deliverables and consistently delivers quality documentation with no escapes
As regulations change and quality systems are merged/aligned, executes 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)
Leads structured problem‑solving initiatives to resolve complex technical issues and documents within appropriate quality system documentation
Seniority level Mid‑Senior level
Employment type Contract
Job function Writing/Editing
Industries Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Aviation and Aerospace Component Manufacturing
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