Document Control Specialist

Akkodis; City of Rochester (NY); On-site; USD 71,635,200 - 97,423,872; Full time

Job summary

Akkodis is seeking a Document Control Specialist in Rochester, NY to manage and maintain controlled documentation in compliance with FDA regulations, ISO standards, and internal quality systems. An Associate’s degree is required, with a minimum of two years’ related experience.

The role includes administering the Document Control System, handling document lifecycles, supporting audits, and training staff to ensure data integrity and regulatory compliance across operations.

Qualifications

• Associate degree in a related discipline is required.
• Minimum two years related experience.
• Experience within an FDA‑regulated environment.
• Proficiency with electronic document management systems such as MasterControl, Agile and Veeva.

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, Deviations, and CAPAs.
• Support internal and external audits by providing accurate and timely documentation.
• Collaborate with cross‑functional teams to ensure documentation supports regulatory and operational needs.
• Train employees in 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).

Skills

Document control

Regulatory compliance

Audit support

Education

Associate degree

Tools

MasterControl

Agile

Veeva

Job description

Job Overview

Akkodis is seeking a Document Control Specialist in Rochester, NY. Must hold an Associate’s degree in a related field. The role is mandatory to manage and maintain controlled documentation in compliance with FDA regulations, ISO standards, and internal quality systems. Must ensure integrity, accessibility, and compliance of all documentation supporting operations.

Rate Range: $25/hr to $34/hr. Negotiable based on experience, education, location and other factors.

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 in 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).

Qualifications

• Associate degree in related discipline is required.
• Minimum two years related experience.
• Experience 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.
• Experience working with ISO 13485.

Benefits

Benefit offerings include medical, dental, vision, life insurance, short‑term disability, voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Benefits provide employees the flexibility to choose the type of coverage that meets their individual needs.

Employees may be eligible for paid leave including Paid Sick Leave and any other paid leave required by federal, state, or local law, as well as Holiday pay where applicable.

Disclaimer: These benefit offerings do not apply to client‑recruited jobs and jobs that are direct hires to a client.

Equal Opportunity Employer (EOE)

Equal Opportunity Employer, Veterans, Disabled.

Legal

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers

Privacy Information

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.