Technical Documentation Specialist

Planet Pharma Group; West Conshohocken (PA); On-site; USD 75,000 - 95,000; Full time

Job summary

Planet Pharma in West Conshohocken, PA is seeking a seasoned Documentation Specialist to review batch records and GMP documentation, ensuring accuracy and regulatory compliance.

You will collaborate with Manufacturing, Quality and Technical Operations, support investigations, and drive continuous improvement of documentation processes.

Qualifications

• Bachelor's degree in a scientific or engineering discipline is preferred.
• 5+ years in pharmaceutical/biotech regulated manufacturing environments.
• Experience reviewing batch records or GMP documentation.

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.

Skills

GMP knowledge

Documentation review

Attention to detail

Communication skills

Problem-solving

Education

Bachelor's degree in science or engineering

Tools

Microsoft Word

Excel

EDMS / electronic document management systems

Job description

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