Technical Editor/Writer

 
Location: West Point, Pennsylvania
Posted On: 8/11/2017
Job Code: PRV_1895_PA
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Job Description
 
Qualifications:
• 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.

Responsibilities:
• Performs technical review and editing of new and revised MMD Quality Management System (QMS) documents
• Reviews new/revised QMS documents for technical adequacy and alignment across the documents within and across chapters/topics.
• Ensures appropriate cross-referencing between documents within and across QMS chapters/topics
• 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
• Partners with document authors to complete the document authoring, review and approval process.
• Maintains a traceability chart for cross-referencing between QMS documents
• Prepares documentation required by sites to implement new QMS documents.
• May perform other tasks related to QMS document management as requested by the QMS Operations Director
Category:IT  code:new
 
 
Job Requirements
 
 
Skills:
• 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
 

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Contact Details
 
Recruiter
Paras Vadukar
 
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