Akkodis
Akkodis is seeking a
Document Control Specialist
role. This is a
Contract
position located in
Victor, NY 14564 . Applicants with a solid background in
FDA regulations, ISO standards, cGMP
are preferred.
Salary Range: $32-$35/hr (W2)
– 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 .
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, 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
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:
California Fair Chance Act
Los Angeles City Fair Chance Ordinance
Los Angeles County Fair Chance Ordinance for Employers
San Francisco Fair Chance Ordinance
#J-18808-Ljbffr
Document Control Specialist
role. This is a
Contract
position located in
Victor, NY 14564 . Applicants with a solid background in
FDA regulations, ISO standards, cGMP
are preferred.
Salary Range: $32-$35/hr (W2)
– 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 .
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, 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
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:
California Fair Chance Act
Los Angeles City Fair Chance Ordinance
Los Angeles County Fair Chance Ordinance for Employers
San Francisco Fair Chance Ordinance
#J-18808-Ljbffr