Job Description

Senior Quality Document Control Specialist

Boston, MA

Schedule: Standard Office Hours, Monday-Friday

Duration: 6-Month Contract

Pay Range: $45.00 - $55.00/hour

Our client is a leading biotechnology company focused on advancing innovative therapies to improve patient outcomes.

Position Summary

The Senior Document Control Specialist will oversee the management, organization, and maintenance of controlled documents within the Quality Management System (QMS). This role is critical in ensuring compliance with regulatory requirements, company policies, and industry standards while supporting efficient pharmaceutical development and manufacturing operations.

Key Responsibilities

• Manage the full lifecycle of controlled documents, including creation, revision, review, approval, distribution, and archival.
• Ensure documents are accurate, up-to-date, and accessible within the electronic document management system (EDMS).
• Collaborate with cross-functional teams to facilitate timely review and approval.
• Maintain compliance with current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Ensure audit readiness by keeping documents compliant and available for internal and external audits.
• Identify and implement improvements to enhance document control efficiency and effectiveness.
• Develop and maintain standard procedures, work instructions, and training materials.
• Provide training and guidance on document control processes.
• Serve as a subject matter expert during audits and inspections.
• Generate and analyze document control metrics and reports.
• Present findings and recommend corrective actions to management.

Qualifications

Required

• Bachelor's degree in Life Sciences, Quality Assurance, Regulatory Affairs, or related field.
• 5-7 years of document control experience in the pharmaceutical, biotechnology, or medical device industry.
• Strong knowledge of cGMP, GDP, and regulatory requirements (FDA, EMA).
• Proficiency with electronic document management systems.
• Excellent organizational, communication, and interpersonal skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Strong attention to detail with a focus on quality and accuracy.

Preferred

• Certification in Document Control or Quality Management.
• Experience with Lean or continuous improvement methodologies.
• Familiarity with global regulatory requirements and international document control standards.

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