Technical Editor

Location: West Point, Pennsylvania
Posted On: 5/5/2017
Job Code: 7359-TE-PA
Job Description
BS in Life Science Field, Engineering Field or related relevant discipline Minimum 7-10 years prior site and/or Global Quality experience in FDA and or EU regulated pharmaceutical, vaccine, biologics, API manufacturing preferred with at least 3 years experience in a technical writer/editor role. Excellent written and oral communication skills. Ability to accurately interpret and apply regulatory expectations to the QMS in a drug, device and biologics manufacturing environment. Strong project management skills. Strong collaboration skills and ability to work in a team environment.

Performs technical review and editing of new and revised MMD Quality Management System (QMS) documents.
1. Reviews new/revised QMS documents for technical adequacy and alignment across the documents within and across chapters/topics.
2. Ensures appropriate cross-referencing between documents within and across QMS chapters/topics.
3. Ensures clarity of documents through correct sequencing of information, use of grammar, content presentation (e.g. use of graphics/tables etc.) and consistency of documents in style, format and terminology.
4. Partners with document authors to complete the document authoring, review and approval process.
5. Maintains a traceability chart for cross-referencing between QMS documents.
6. Prepares documentation required by sites to implement new QMS documents.
7. May perform other tasks related to QMS document management as requested by the QMS Operations Director.
Category:IT  code:new
Job Requirements
Technical Editor
Minimum 7-10 years prior site and/or Global Quality experience in FDA

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Contact Details
Shweta Thapliyal