Senior Documentation Systems Specialist - cGMP QA

aftons-job-board; 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 in Virginia. The role focuses on maintaining master documents, controlled documents, batch records, and related databases to ensure compliance and data integrity.

Strong cGMP knowledge and document-control experience are essential. Responsibilities include notifying stakeholders of changes, approving deviations, supporting audits, and providing cross-functional QA support.

Qualifications

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

Responsibilities

• Administer and control master documents and databases.
• Notify stakeholders of changes to controlled documents.
• Maintain change requests, investigation docs, batch records.
• Issue validation protocols and navigate GMP documentation.
• Support audits and VIP visits with documentation requests.
• Provide general admin support to QA and operations.

Skills

Attention to Detail

Documentation skills

Regulatory Compliance

Communication Skills

Independent Work

GMP Knowledge

Education

Bachelor's degree

5+ years pharma administration

Tools

MasterControl

Veeva

Job description

Afton Scientific is seeking an experienced Documentation Systems Specialist III to join our Quality Assurance team in Virginia. The role focuses on maintaining master documents, controlled documents, batch records, and related databases to ensure compliance and data integrity.

Strong cGMP knowledge and document-control experience are essential. Responsibilities include notifying stakeholders of changes, approving deviations, supporting audits, and providing cross-functional QA support.