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Pharmaceutical Technical Editor- Quality Document Management
Ref No.: 18-40715
Location: West Point, Pennsylvania
Position Type:Contract
Shift:First
Job Category:Biotech/Pharmaceutical
Benefits:401K, Dental Insurance, Medical Insurance
*2.5 year contract position with additional opportunity based upon performance and continued business need. Likely start date of late 2018 or beginning of 2019*

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 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. 

Pay Rate: $53.00 per hour
Drug and background screenings required

On-Board Services provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics. Additionally, our client for this opening does not permit the use of Corp-to-Corp (C2C) candidates.