Akkodis Group Nordics · 13 hours ago
Document Control Specialist Job in Rochester, NY:
Victor, NY
Full-time
Onsite
Entry, Mid Level
$30/hr - $38/hr
2+ years expAkkodis Group Nordics is seeking a detail-oriented and highly organized Document Control Specialist to manage and maintain controlled documentation in compliance with FDA regulations and ISO standards. This role is critical to ensuring the integrity, accessibility, and regulatory compliance of all documentation supporting the company's operations.
Embedded SystemsSoftware
Responsibilities
Administer and maintain the Document Control System (electronic and paper-based)
Manage document lifecycle including creation, review, approval, distribution, revision, and archival
Ensure compliance with 21 CFR Part 11, 21 CFR 820, and ISO 13485 requirements
Process Document Change Orders (DCOs), Deviations, and CAPAs
Support internal and external audits by providing accurate and timely documentation
Collaborate with cross-functional teams (QA, RA, R&D, Manufacturing) to ensure documentation supports regulatory and operational needs
Train employees on document control procedures and systems
Monitor and report on document control metrics and compliance status
Maintain Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR)
Qualification
Required
Associate's or Bachelor's degree in a related field (Life Sciences, Quality, Regulatory Affairs preferred)
2+ years of experience in document control within an FDA-regulated environment
Proficiency with electronic document management systems (e.g., MasterControl, Agile, Veeva)
Strong understanding of FDA regulations, ISO standards, and cGMP practices
Excellent organizational skills and attention to detail
Strong communication and interpersonal skills
Ability to work independently and manage multiple priorities
Preferred
Experience supporting FDA inspections or ISO audits
Familiarity with validation documentation and quality system records
Knowledge of risk management and change control processes
Benefits
Medical
Dental
Vision
Life insurance
Short-term disability
Additional voluntary benefits
EAP program
Commuter benefits
401K plan
Paid Sick Leave
Holiday pay
Company
Akkodis Group Nordics
Akkodis Group Nordics, operates as a specialized tech cluster, combining expertise in Digital Engineering and Edge Technology.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Reiten & Co
2020-03-16Acquired
2009-05-01Private Equity
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