Akkodis
Document Control Specialist Job in Rochester, NY:
Akkodis, Victor, New York, United States, 14564
Document Control Specialist Job in Rochester, NY:
Contract Pay Rate Range : $22.00- 34.00 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 at
Thomas.McCarthy@
akkodis.com
Pay Details:
$30.00 to $38.00 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, 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.
Equal Opportunity Employer/Veterans/Disabled
Military connected talent encouraged to apply
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www-uat.modis.com/en-us/candidate-privacy
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
Massachusetts Candidates Only:
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Contract Pay Rate Range : $22.00- 34.00 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 at
Thomas.McCarthy@
akkodis.com
Pay Details:
$30.00 to $38.00 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, 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.
Equal Opportunity Employer/Veterans/Disabled
Military connected talent encouraged to apply
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www-uat.modis.com/en-us/candidate-privacy
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
Massachusetts Candidates Only:
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.