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Document Control Specialist

Company: System One
Location: Exton
Posted on: January 16, 2022

Job Description:

Title: Document Control Specialist
Location: Exton, Pa
Schedule: M-F 8am to 5pm
Type: 6-contract to hire
Start date: Immediate
Tracking and notification of past due training to employees and managers.
Process Document Change Requests (DCR), create/review/revise GxP documents in QMS for format and grammar, and perform edits.
Collaborate with process/document owners and stakeholders to prioritize, release, and implement quality system changes and updates to SOPs.
Ensure record-keeping and documentation compliance with FDA requirements.
Ensure timely coordination with document approvers, originators, and Document Control.
Maintains master files and the archives files for the following records: Master Batch Records, Analytical Test Methods, and Raw Material Specifications.
Distributes effective versions of controlled documents to satellite binders and makes old versions of controlled versions obsolete (Master Batch Records, Analytical Test Methods, Standard Operating Procedures, Raw Material Specifications).
Assist with CSV (Computer System Validation) for EMS projects.
Assists the Quality Systems Department as needed.
Assists the Quality Systems Supervisor in daily operations, as needed.
Trending of open, pending and completed Document Change Requests.
Bachelor of Science degree in a scientific discipline or a minimum combination of 3 years' experience in a similar document control/training role in the biologics or pharmaceutical industry.
Experience in a similar role in the biologics or pharmaceutical industry a plus
Proficiency Microsoft products including Outlook, SharePoint, Word, PowerPoint, and Excel.
MasterControl (Other EMS System) experience a plus.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

Keywords: System One, Wilmington , Document Control Specialist, Other , Exton, Delaware

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