Senior Documentation & Quality Records Specialist

Afton Scientific; Charlottesville (VA); On-site; USD 34,000 - 48,000; Full time

Job summary

Afton Scientific is seeking an experienced Documentation Systems Specialist III to join our Quality Assurance team, focusing on controlling master documents and related databases within a regulated pharmaceutical environment.

You will administer controlled documents, notify stakeholders of changes, support audits, and collaborate with cross-functional teams to ensure compliance with cGMP and applicable FDA/EU guidance.

Qualifications

• Bachelor's degree or 5+ years of experience in pharmaceutical administration or a related role.
• GMP knowledge and experience in a regulated environment (pharma/biopharma).
• Experience using GMP-compliant document management systems (MasterControl, Veeva or similar).
• Advanced computer skills (Word/Excel) with ability to learn databases.

Responsibilities

• Administer and control master documents and associated databases.
• Maintain approved controlled documents (SOPs, policies, batch records, 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 ensure closure of completed protocols.
• Write, review, and edit master documents (SOPs, batch records, specs).
• Review and approve ODRs and Change Control documents as applicable.
• Support audits and regulatory visits by facilitating documentation requests.

Skills

Attention to detail

Written communication

Documentation management

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree

5+ years pharma admin/ documentation

Tools

MasterControl

Veeva

Job description

Afton Scientific is seeking an experienced Documentation Systems Specialist III to join our Quality Assurance team, focusing on controlling master documents and related databases within a regulated pharmaceutical environment.

You will administer controlled documents, notify stakeholders of changes, support audits, and collaborate with cross-functional teams to ensure compliance with cGMP and applicable FDA/EU guidance.