Document Control Specialist
Company: System One
Posted on: January 16, 2022
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
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
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
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
Trending of open, pending and completed Document Change
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
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
Keywords: System One, Wilmington , Document Control Specialist, Other , Exton, Delaware
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