Document Control Specialist in Farmington

Document Control Specialist

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: $25-30/hr w2, The salary may be negotiable based on experience, education, geographic location, and other factors.

Key Responsibilities

• Ensure compliance with 21 CFR Part 11, 21 CFR 820, and ISO 13485 requirements.
• Process Document Change Orders (DCOs), Deviations, and CAPAs.
• Collaborate with cross-functional teams (QA, RA, R&D, Manufacturing) to ensure documentation supports regulatory and operational needs.
• 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., Master Control, Agile, Veeva).
• Strong understanding of FDA regulations, ISO standards, and cGMP practices.

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.

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

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