Senior Documentation Systems Specialist – GMP & QA

Afton Scientific, LLC; Charlottesville (VA); On-site; USD 52,000 - 73,000; Full time

Job summary

Afton Scientific, LLC is seeking an experienced Documentation Systems Specialist III to join our Quality Assurance team in Virginia. The role focuses on maintaining the integrity of master documents and databases supporting pharmaceutical manufacturing, packaging, and labeling operations.

The successful candidate will manage documentation controls, support audits, and collaborate across QA, QC, and Operations to ensure compliant, timely documentation throughout cGMP activities.

Qualifications

• Bachelor's degree or 5+ years in pharmaceutical administration, documentation, or related role.
• GMP knowledge and experience in regulated environments.
• Experience with GMP-compliant document management systems (MasterControl, Veeva or similar).
• Advanced MS Word/Excel skills and ability to learn new databases.
• Strong written and verbal communication abilities.

Responsibilities

• Administer and control of master documents and databases.
• Maintain approved controlled documents (SOPs, directives, policies, batch records).
• Notify stakeholders of changes to controlled documents.
• Maintain change requests and investigation documentation.
• Assign lot numbers and issue batch records.
• Issue validation protocols and finalize completed protocols.
• Write/edit master documents (SOPs, batch records, specifications).
• Review/approve Deviation Reports and Change Control docs.
• Support audits and regulatory visits with documentation requests.
• Provide general administrative support to QA and operations.

Skills

Communication skills

Attention to detail

Independent problem solving

Strong writing skills

Team collaboration

Education

Bachelor's degree or 5+ years pharma admin

Tools

MasterControl

Veeva

Microsoft Word

Excel

Job description

Afton Scientific, LLC is seeking an experienced Documentation Systems Specialist III to join our Quality Assurance team in Virginia. The role focuses on maintaining the integrity of master documents and databases supporting pharmaceutical manufacturing, packaging, and labeling operations.

The successful candidate will manage documentation controls, support audits, and collaborate across QA, QC, and Operations to ensure compliant, timely documentation throughout cGMP activities.