Documentation Systems Specialist III (Pharmaceutical Manufacturing)

Location: Charlottesville, Virginia, United States; regular on-site attendance is required.

Salary: $25.00–$35.00 per hour

Company

hirify.global is a Virginia-based contract manufacturing organization providing sterile pharmaceutical manufacturing, filling, packaging, labeling, laboratory, validation, and pharmaceutical support services.

What you will do

• Administer documentation systems, master lists, controlled documents, and associated databases.
• Maintain and issue SOPs, directives, policies, batch records, protocols, specifications, and validation documents.
• Notify clients and stakeholders about controlled-document changes and maintain change-request and investigation records.
• Assign lot numbers, issue batch records, and review or approve applicable deviation and change-control documentation.
• Support audits, regulatory or client visits, documentation requests, and qualified inspection activities in Finishing Operations.
• Write, review, edit, and process master documents while providing administrative and stakeholder support.

Requirements

• Bachelor’s degree or at least five years of experience in pharmaceutical administration, documentation, or a related role.
• Experience in biopharmaceutical production or Quality Control.
• Comprehensive knowledge of cGMP requirements and FDA and EU guidance for aseptic processing.
• Experience with a GMP-compliant document management system, such as MasterControl or Veeva.
• Advanced Microsoft Word and Excel skills, strong communication, accurate recordkeeping, and the ability to work with minimal supervision.
• Ability to attend the Charlottesville site regularly, stand for extended periods, lift up to 50 pounds, and perform required bending and reaching.

Nice to have

• Experience administering controlled documentation in a pharmaceutical or biopharmaceutical environment.
• Experience with SOPs, batch records, specifications, protocols, change control, and operational deviations.
• Experience supporting internal, client, or regulatory audits.
• Cross-functional experience with Quality Assurance, Quality Control, Operations, and other departments.

Culture & Benefits

• Exposure to the Quality Management System and controlled-document processes.
• Work across pharmaceutical manufacturing, validation, investigations, audits, and change controls.
• Opportunities for professional development and career growth within hirify.global.
• Professional collaboration with coworkers, internal customers, vendors, and clients.