Quality Document Specialist

Role overview

United Pharma is hiring a Quality Document Specialist to help run quality systems and document control processes in a pharmaceutical/biotech setting. The position centers on handling controlled records, keeping training compliance on track, and contributing to audit readiness while working within GxP and broader quality system expectations.

Core responsibilities

• Maintain controlled quality documents such as SOPs, work instructions, forms, and quality records using Veeva Vault QualityDocs.
• Handle document routing, review and approval steps, metadata upkeep, and scheduled document reviews.
• Coordinate training assignments, track completion progress, and assist with ComplianceWire administration.
• Prepare for audits and inspections by locating, arranging, and providing quality documents and training evidence.
• Support change control activities, document revisions, and other quality system compliance tasks.
• Work in line with GxP rules, GDP standards, and internal quality requirements.

Qualifications

The ideal candidate should bring 2 to 4 years of experience in Quality Systems, Document Control, or QA within pharma or biotech. Prior exposure to Veeva Vault QualityDocs and ComplianceWire is preferred. A strong working understanding of GxP, GDP, and 21 CFR Part 11 is important, along with solid organizational, communication, and documentation skills. The role also calls for someone who can juggle several priorities in a regulated, fast-moving environment.

Additional information

This is a contract position based onsite in New Jersey, United States.