Senior Pharmaceutical Documentation Systems Specialist

Rippling, Inc.; Charlottesville (VA); On-site; USD 34,000 - 48,000; Full time

Job summary

Afton Scientific seeks an experienced Documentation Systems Specialist III to join its Quality Assurance team in Virginia. You will administer master documents and databases, ensuring accuracy, traceability, and compliance with cGMP and FDA/EU guidelines.

The role requires strong documentation skills, familiarity with GMP-driven systems like MasterControl or Veeva, and the ability to collaborate across QA, Operations, and Regulatory functions to support audits, changes, and validations.

Qualifications

• Bachelor's degree or 5+ years of experience in pharmaceutical administration, documentation, or a related role.
• General experience within biopharmaceutical production or Quality Control.
• Comprehensive knowledge of cGMP requirements and applicable FDA and EU guidance related to aseptic processing.
• Experience using a GMP-compliant document management system, such as MasterControl, Veeva, or a comparable platform.
• Advanced computer skills, including Microsoft Word and Excel, with the ability to learn additional database applications.
• Strong written and verbal communication skills.
• Ability to maintain accurate records and manage documentation with a high degree of attention to detail.
• Ability to work effectively with minimal supervision.

Responsibilities

• Support the overall administration and management of Afton's Documentation Systems.
• Maintain master lists and approved controlled documents, including SOPs, directives, policies, batch records, protocols, and specifications.
• Notify clients and appropriate stakeholders of changes to controlled documents.
• Maintain records of approved change requests and investigation documentation.
• Assign lot numbers and issue batch records.
• Issue validation protocols for execution and process completed protocols following closure.
• Write, review, and edit master documents, including SOPs, batch records, and specifications.
• Review and approve Operational Deviation Reports (ODRs) and Change Control documentation, as applicable.
• Support audits and pharmaceutical VIP visits by facilitating documentation requests.
• Provide general administrative support as assigned.
• Provide inspection support to Finishing Operations, as qualified.
• Maintain positive and professional working relationships with coworkers, internal customers, and vendors.

Skills

Document management

GMP compliance

Attention to detail

Written and verbal communication

Independent work

Education

Bachelor's degree

Tools

MasterControl

Veeva

Microsoft Word

Microsoft Excel

Job description

Afton Scientific seeks an experienced Documentation Systems Specialist III to join its Quality Assurance team in Virginia. You will administer master documents and databases, ensuring accuracy, traceability, and compliance with cGMP and FDA/EU guidelines.

The role requires strong documentation skills, familiarity with GMP-driven systems like MasterControl or Veeva, and the ability to collaborate across QA, Operations, and Regulatory functions to support audits, changes, and validations.