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Document Control Specialist

$28 - $30 per hour

Akkodis

Akkodis is seeking a Document Control Specialist role is a Contract with a client located in Victor NY 14564 . Ideally looking for applicants to have a solid background in FDA regulations, ISO standards, cGMP would come as a big plus. Salary Range: $28-$30/hr. The pay may be negotiable based on experience, education, geographic location, and other factors. Key Responsibilities Manage the complete document lifecycle including creation, review, approval, revision, distribution, and archival. Maintain electronic document management systems (MasterControl, Agile, Veeva, or similar). Process Document Change Orders (DCOs), Deviations, and CAPAs. Ensure compliance with FDA regulations (21 CFR Part 11, 21 CFR 820), ISO 13485, and cGMP requirements. Maintain DHF, DMR, and DHR documentation. Support internal/external audits and regulatory inspections. Partner with QA, RA, R&D, and Manufacturing teams to ensure documentation accuracy. Train employees on document control procedures and quality systems. Required Qualifications Associate's or Bachelor's degree in Life Sciences, Quality, Regulatory Affairs, or a related field. 2+ years of document control experience in an FDA-regulated environment. Experience with electronic document management systems (MasterControl, Agile, Veeva, etc.). Strong understanding of FDA regulations, ISO 13485, and quality management systems. Excellent organizational, communication, and multitasking skills. Preferred Experience supporting FDA inspections and ISO audits. Knowledge of validation documentation, change control, and risk management processes. Benefits 401(k) with match Equal Opportunity Employer/Veterans/Disabled #J-18808-Ljbffr

Vacancy posted 4 days ago
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