Document Control Specialist

Akkodis; Town of Victor (NY); On-site; USD 38,572 - 41,328; Part time

Benefits offered by this job

401(k) with match

Job summary

Akkodis is hiring a Document Control Specialist for a Contract position in Victor, NY. The role involves managing document lifecycles, ensuring compliance with FDA regulations and ISO standards.

Applicants should have a degree in Life Sciences or a related field, 2+ years of experience in document control, and familiarity with electronic document management systems. The position offers a salary range of $28-$30/hr with possible negotiation based on experience.

Qualifications

• 2+ years of document control experience in an FDA-regulated environment.
• Experience with electronic document management systems.
• Strong understanding of FDA regulations and ISO 13485.

Responsibilities

• Manage the complete document lifecycle including creation, review, and archival.
• Maintain electronic document management systems.
• Ensure compliance with FDA regulations and ISO standards.

Skills

Document control

FDA regulations

ISO standards

cGMP

Organizational skills

Communication skills

Multitasking

Education

Associate's or Bachelor's degree in Life Sciences

Quality or Regulatory Affairs degree

Tools

MasterControl

Agile

Veeva

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: $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.

Benefits

• 401(k) with match

Equal Opportunity Employer/Veterans/Disabled