Technical Writer

Job Title:

Document Control Specialist

Client is unable to provide visa sponsorship now or in the future.

We are seeking a diligent and detail-oriented Document Control Specialist to facilitate the change control process from initiation through all workflow steps to implementation. You will review completed change orders for content and approvals, ensuring compliance with ISO, FDA, and internal requirements. You will be responsible for managing all documentation related to manufacturing, quality control, quality assurance, and distribution of pharmaceutical products, including the development and maintenance of document control systems.

• Facilitate the change control process from initiation to implementation, including reviewing completed change orders for content and approvals.
• Review change orders and items for completeness and compliance with ISO, FDA, and internal template and procedure requirements in a timely manner.
• Select and/or verify required approvers of changes per procedures.
• Manage and maintain all documentation related to manufacturing, quality control, quality assurance, and distribution of pharmaceutical products, including batch records, standard operating procedures, specifications, and other critical documents.
• Develop and maintain document control systems to ensure the accuracy, completeness, and accessibility of all documentation.
• Use the electronic Quality Management System for controlled documentation approval, revision, and obsoletion.
• Ensure compliance with all regulatory requirements, including FDA, cGMP, and other industry standards.
• Review documents for format, accuracy, and compliance with existing procedures, providing feedback on content as appropriate in collaboration with area experts.
• Complete required documentation accurately and in a timely manner following Good Documentation Practices (GDP).
• Support the Training Program by entering training data and monitoring completion.
• Manage and maintain the training matrix and job-by-function report.

• Experience in document control and quality standards.
• Knowledge of ISO and FDA regulatory requirements.
• Strong attention to detail and organizational skills.
• Ability to manage both electronic and physical records.
• Proficiency in using electronic Quality Management Systems.
• Good Documentation Practices (GDP) knowledge.

• Associate's degree or high school diploma required.
• Experience with Greenlight Guru is a plus.
• Familiarity with mechanical drawings and inspection processes.
• Knowledge of Quality Management Systems (QMS).

This role is based in an onsite environment, operating on the 6th and 8th floors of a collaborative setting. Employees frequently travel between the R&D team and Quality team, fostering a highly interactive and collaborative work environment. The company operates in two locations in Kendall, with one location in a high-rise building housing the Quality team, and the other in a two-story building with a surgery center on the first floor and the design team on the second floor.

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

The pay range for this position is $28.00 - $35.00/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 7, 2026.

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