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 specializing in small-batch sterile injectable manufacturing, packaging, labeling, analytical and microbiology laboratory services, and pharmaceutical support from clinical trials through commercial production.

What you will do

• Administer and control documentation systems, master lists, approved controlled documents, and associated databases.
• Maintain SOPs, directives, policies, batch records, protocols, specifications, change requests, and investigation records.
• Assign lot numbers, issue batch records and validation protocols, and process completed protocols after closure.
• Write, review, and edit master documents and review applicable Operational Deviation Reports and Change Control documentation.
• Support audits, pharmaceutical VIP visits, documentation requests, and qualified inspection activities in Finishing Operations.
• Collaborate with Quality Assurance, Quality Control, Operations, clients, vendors, and internal stakeholders.

Requirements

• Bachelor's degree or at least five years of experience in pharmaceutical administration, documentation, or a related field.
• Experience in biopharmaceutical production or Quality Control and comprehensive knowledge of cGMP requirements and FDA and EU guidance for aseptic processing.
• Experience with a GMP-compliant document management system such as MasterControl, Veeva, or a comparable platform.
• Advanced Microsoft Word and Excel skills, strong written and verbal communication, and the ability to learn additional database applications.
• High attention to detail, accurate recordkeeping, organization, and the ability to work independently with minimal supervision.
• Ability to attend the workplace regularly on site, stand for extended periods, lift up to 50 pounds, and bend and reach as required.

Nice to have

• Experience administering controlled documentation in a pharmaceutical or biopharmaceutical environment.
• Experience with SOPs, batch records, specifications, protocols, Change Control, and Operational Deviation processes.
• Experience supporting internal, client, or regulatory audits and working cross-functionally across quality and operations departments.

Culture & Benefits

• Exposure to the Quality Management System and controlled-document processes.
• Opportunities to support pharmaceutical manufacturing, validation, audits, investigations, and change controls.
• Professional development and career growth in cGMP documentation and electronic document management systems.
• Work with a company serving clients in 18 countries and maintaining relationships with FDA, PMDA, and MHRA requirements.