Technical Documentation Specialist

Responsibilities

• Review batch records and manufacturing documentation for accuracy and GMP compliance.
• Identify and resolve documentation discrepancies, errors, and omissions.
• Collaborate with Manufacturing, Quality, and Technical Operations teams.
• Support investigations and documentation corrections as needed.
• Ensure records meet internal procedures and regulatory requirements.
• Maintain accurate documentation and review tracking.
• Assist with continuous improvement initiatives related to manufacturing documentation.

Qualifications

• Bachelor’s degree in a scientific or engineering discipline preferred.
• 5+ years of experience in pharmaceutical, biotechnology, or related regulated manufacturing environments.
• Experience reviewing batch records, production records, or GMP documentation.
• Strong understanding of GMP regulations and manufacturing practices.
• Excellent attention to detail and organizational skills.
• Strong communication and problem-solving abilities.

Preferred Experience

• Commercial manufacturing experience.
• Drug substance or biologics manufacturing experience.
• Experience with quality systems and electronic documentation platforms.

Technical Skills

• GMP documentation review
• Batch record reconciliation
• Microsoft Office Suite (Word, Excel, Outlook)
• Electronic quality or document management systems