Pharma Documentation Systems Lead (GMP & QA)

Virginia Economic Development Partnership; Charlottesville (VA); On-site; USD 34,000 - 48,000; Full time

Job summary

Afton Scientific is seeking a Documentation Systems Specialist III to support our Quality Assurance team. The role focuses on administering master documents and databases to ensure cGMP-compliant documentation and data integrity across pharmaceutical operations.

Key duties include maintaining controlled documents (SOPs, batch records, specifications), reviewing change requests, and supporting audits and VIP visits with meticulous attention to detail.

Qualifications

• Bachelor's degree or 5+ years in pharmaceutical administration, documentation, or related role.
• GMP knowledge with FDA/EU guidance for aseptic processing.
• Experience with GMP-compliant document management systems.

Responsibilities

• Support administration and management of Documentation Systems.
• Maintain master lists and controlled documents (SOPs, directives, policies, batch records, protocols, specifications).
• Notify stakeholders of changes to controlled documents.
• Maintain records of change requests and investigation documentation.
• Assign lot numbers and issue batch records.
• Issue validation protocols and follow through completed protocols.
• Write, review, and edit master documents (SOPs, batch records, specifications).
• Review and approve ODRs and Change Control documentation.
• Support audits and pharmaceutical VIP visits by facilitating documentation requests.
• Provide general administrative support; inspection support to Finishing Operations as qualified.

Skills

Attention to Detail & Accuracy

Documentation & Data Integrity

Quality & Regulatory Compliance

Organization & Prioritization

Communication & Collaboration

Accountability & Follow-Through

Independent Problem Solving

Customer & Stakeholder Support

Education

Bachelor's degree in related field

Tools

MasterControl

Veeva

Job description

Afton Scientific is seeking a Documentation Systems Specialist III to support our Quality Assurance team. The role focuses on administering master documents and databases to ensure cGMP-compliant documentation and data integrity across pharmaceutical operations.

Key duties include maintaining controlled documents (SOPs, batch records, specifications), reviewing change requests, and supporting audits and VIP visits with meticulous attention to detail.