Documentation Systems Lead - cGMP & QA

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

Job summary

Afton Scientific in Virginia is seeking an experienced Documentation Systems Specialist III to join its Quality Assurance team. The role focuses on maintaining the integrity and control of master documents and related databases, supporting manufacturing and QA operations.

You will write and review master documents and change controls, assist audits, and collaborate cross-functionally with QA, Operations, and vendors; onsite work required with opportunities to contribute to regulatory compliance

Qualifications

• Bachelor's degree or 5+ years of pharma documentation experience.
• GMP/cGMP knowledge with FDA/EU guidance exposure.
• Experience with GMP document management systems (MasterControl, Veeva).
• Strong MS Word/Excel skills and ability to learn new databases.

Responsibilities

• Administer and control master documents and related databases.
• Maintain approved controlled documents (SOPs, batch records, specs).
• Notify stakeholders of changes to controlled documents.
• Maintain change requests and investigation records.
• Issue batch records and validation protocols as needed.
• Support audits and regulatory visits with documentation requests.

Skills

Attention to Detail

Documentation

Data Integrity

Communication

Independent Work

Education

Bachelor's degree

Tools

MasterControl

Veeva

Microsoft Word

Microsoft Excel

Job description

Afton Scientific in Virginia is seeking an experienced Documentation Systems Specialist III to join its Quality Assurance team. The role focuses on maintaining the integrity and control of master documents and related databases, supporting manufacturing and QA operations.

You will write and review master documents and change controls, assist audits, and collaborate cross-functionally with QA, Operations, and vendors; onsite work required with opportunities to contribute to regulatory compliance