Document Control Specialist; FDA

Document Control Specialist

The Document Control Specialist is responsible for managing and maintaining controlled documentation to support manufacturing, quality control, quality assurance, and distribution operations within a regulated pharmaceutical environment. This role ensures all documentation complies with FDA, cGMP, ISO, and internal quality system requirements while supporting change control and training processes.

• Facilitate the change control process from initiation through implementation, ensuring all workflow steps, content, and approvals are complete and compliant.
• Review change orders and associated documentation for accuracy, completeness, and adherence to ISO, FDA, cGMP, and internal procedures and templates.
• Identify, select, and verify required approvers in accordance with established procedures.
• Manage and maintain controlled documentation, including batch records, SOPs, specifications, and other quality‑critical records, in both electronic and physical formats.
• Develop, implement, and maintain document control systems that ensure document accuracy, version control, accessibility, and traceability.
• Utilize the electronic Quality Management System (QMS) for document creation, review, approval, revision, and obsolescence.
• Ensure ongoing compliance with FDA regulations, cGMP requirements, and applicable industry standards.
• Review documents for formatting, technical accuracy, and procedural compliance; provide feedback and collaborate with subject matter experts as needed.
• Complete documentation activities in accordance with Good Documentation Practices (GDP), ensuring accuracy and timeliness.
• Support the training program by entering training records, monitoring completion, and maintaining training documentation.
• Manage and maintain the training matrix and job‑by‑function training reports.

Required:

• Document Control experience in a regulated environment
• Knowledge of Quality Standards and Good Documentation Practices (GDP)
• Technical writing experience
• High School Diploma or Associate’s Degree

Preferred:

• Regulatory experience within FDA‑regulated industries
• Familiarity with FDA and cGMP requirements
• Ability to read and interpret mechanical drawings
• Inspection and quality audit support experience
• General QMS knowledge

This is a Contract to Hire position based out of Miami, FL.

The pay range for this position is $28.00 - $33.50/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long‑term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Miami, FL.

This position is anticipated to close on Mar 6, 2026.

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccom for other accommodation options.