Document Control Specialist Job in Rochester, NY:

Document Control Specialist Job in Rochester, NY:

Contract Pay Rate Range : $30.00- 38.00 per hour based on experience, education, geographic location and other factors.

Please no 3rd party or c2c candidates

We are seeking a detail-oriented and highly organized Document Control Specialist to manage and maintain controlled documentation in compliance with FDA regulations, ISO standards, and internal quality systems. This role is critical to ensuring the integrity, accessibility, and regulatory compliance of all documentation supporting our operations.

Key Responsibilities of the Document Control Specialist Job in Rochester, NY:

• 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).

Qualifications of the Document Control Specialist Job in Rochester, NY:

• 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 Skills

• Experience supporting FDA inspections or ISO audits.
• Familiarity with validation documentation and quality system records.
• Knowledge of risk management and change control processes.

For more information or to be considered for the Document Control Specialist Job in Rochester, NY please contact Thomas McCarthy atThomas.McCarthy@akkodis.com

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or 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.

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

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

· San Francisco Fair Chance Ordinance