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Akkodis · 2 months ago

Document Control Specialist Job in Rochester, NY:

Rochester, NY

Contract

Onsite

Entry, Mid Level

$22/hr - $34/hr

2+ years exp

Akkodis 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 and regulatory compliance of all documentation supporting the company's operations.

Information Technology & Services

H1B Sponsor Likely

Hiring Manager

Thomas S. McCarthy

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

Document Control SystemFDA regulationsISO standardsElectronic document managementQuality system recordsOrganizational skillsCommunication skillsInterpersonal skills

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

An EAP program

Commuter benefits

A 401K plan

Paid Sick Leave

Holiday pay

Company

Akkodis

Glassdoor3.3

Akkodis provides digital engineering solutions for sustainable and innovative industries.

Zug, Zug, CHE

10001+ employees

https://www.akkodis.com

H1B Sponsorship

Akkodis has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (141)

2024 (121)

2023 (67)