Remote Medical Device Document Control Specialist

Actalent; United States; Remote; USD 39,000 - 47,000; Part time

Benefits offered by this job

Remote work options

Job summary

Actalent is seeking a Document Control Specialist to administer and maintain the document control system, ensuring controlled documents, records, and quality system documentation are reviewed, approved, distributed, revised, archived, and retained in alignment with FDA 21 CFR Part 820, QSR, ISO standards and MDSAP.

This fully remote contract role based out of Largo, FL requires an Associate's degree (Bachelor's preferred) and 2+ years in document control within a regulated industry, with

Qualifications

• Associate degree or higher in a relevant field with exposure to regulated environments.
• Minimum 2 years in document control within a regulated industry.
• Experience in medical device, pharmaceutical, biotechnology, or healthcare is preferred.
• Knowledge of FDA 21 CFR Part 820, QSR, ISO, MDSAP and GDP.
• Hands-on experience with electronic document management systems (eDMS).
• Proficiency in Word, Excel, PowerPoint, Outlook.
• Strong organizational skills and meticulous attention to detail.
• Excellent written and verbal communication abilities.
• Ability to manage multiple priorities and meet deadlines.
• Maintain confidentiality and data integrity in documentation.

Responsibilities

• Manage the complete document lifecycle: creation, review, approval, distribution, revision, obsolescence, archival.
• Maintain electronic and paper-based document control systems for accuracy and access.
• Process ECOs, DCOs, and related documentation updates in a compliant manner.
• Route and secure approvals for SOPs, WI, Forms, Specifications, DMRs and other records.
• Maintain revision histories and document traceability per quality system requirements.
• Support compliance with QSR, ISO, MDSAP and regulatory requirements.
• Perform periodic audits of controlled documentation for accuracy and compliance.
• Coordinate document issuance and training related to new or revised procedures.
• Maintain retention and archival processes per policies and regulations.
• Assist with audits by providing requested documentation and evidence.
• Support CAPA, NCR, Risk Management files and related records.
• Track and report document control metrics to support continuous improvement.
• Collaborate with Quality, Regulatory Affairs, Engineering, Manufacturing, and Operations.
• Ensure templates, numbering, and formatting standards are consistently applied.
• Participate in continuous improvement initiatives for documentation processes.
• Perform data entry and quality control checks on documentation.

Skills

Document control

Records management

Regulatory compliance

Attention to detail

Communication skills

Time management

Confidentiality

Quality documentation

GDP knowledge

Education

Associate's degree in Business Administration, Life Sciences, Engineering, Quality, or related field

Bachelor's degree preferred in Business Administration, Life Sciences, Engineering, or related discipline

Tools

MasterControl

ETQ

Veeva

Arena

Microsoft Office Suite

Job description

Actalent is seeking a Document Control Specialist to administer and maintain the document control system, ensuring controlled documents, records, and quality system documentation are reviewed, approved, distributed, revised, archived, and retained in alignment with FDA 21 CFR Part 820, QSR, ISO standards and MDSAP.

This fully remote contract role based out of Largo, FL requires an Associate's degree (Bachelor's preferred) and 2+ years in document control within a regulated industry, with