Job Description
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.
ResponsibilitiesReview 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 absolution.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.
Essential SkillsExperience 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.
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Pay and BenefitsThe pay range for this position is $20.00 - $27.00
• 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)
Workplace Type
This is a fully onsite position in Miami,FL.
Application Deadline
This position will be accepting applications until Jan 2, 2025.
About Actalent
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.
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our peopleThe 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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.