What are the responsibilities and job description for the Document Control Specialist position at Akkodis?
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: $28-$30/hr., The pay may be negotiable based on experience, education, geographic location, and other factors.
Key Responsibilities:
- Manage the complete document lifecycle including creation, review, approval, revision, distribution, and archival.
- Maintain electronic document management systems (MasterControl, Agile, Veeva, or similar).
- Process Document Change Orders (DCOs), Deviations, and CAPAs.
- Ensure compliance with FDA regulations (21 CFR Part 11, 21 CFR 820), ISO 13485, and cGMP requirements.
- Maintain DHF, DMR, and DHR documentation.
- Support internal/external audits and regulatory inspections.
- Partner with QA, RA, R&D, and Manufacturing teams to ensure documentation accuracy.
- Train employees on document control procedures and quality systems.
Required Qualifications:
- Associate's or Bachelor's degree in Life Sciences, Quality, Regulatory Affairs, or a related field.
- 2 years of document control experience in an FDA-regulated environment.
- Experience with electronic document management systems (MasterControl, Agile, Veeva, etc.).
- Strong understanding of FDA regulations, ISO 13485, and quality management systems.
- Excellent organizational, communication, and multitasking skills.
Preferred:
- Experience supporting FDA inspections and ISO audits.
- Knowledge of validation documentation, change control, and risk management 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 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
Salary : $28 - $30