Job Description

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: $32-$35/hr. W2 , The salary may be negotiable based on experience, education, geographic location, and other factors.

Key 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).

Qualifications

• 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.

If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, feel free to contact me at govind.choudhary@akkodisgroup.com.

Equal Opportunity Employer/Veterans/Disabled

Benefits offerings include but are not limited to:

• 401(k) with match

• Medical insurance

• Dental Insurance

• Vision assistance

• Paid Holidays Off

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit .

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

Job Tags

Similar Jobs