Quality Document Specialist

Quality Document Specialist

We are seeking a Quality Document Specialist to support the Quality Systems team within a pharmaceutical/biotech environment for a 6-12 month contract. This consultant will play a key role in managing controlled documentation and training processes, ensuring compliance with GxP standards, and supporting audit readiness activities.

Location: Warren, New Jersey - 3 days on site & 2 days remote

Pay Rate: $55-$70 /hr

Key Responsibilities

• Process controlled documents (SOPs, Work Instructions, forms) through the Veeva Vault QualityDocs workflow
• Manage document metadata and ensure accuracy and completeness
• Route documents for review and approval in accordance with established procedures
• Execute periodic document reviews under the guidance of senior QA staff

Training Management (ComplianceWire)

• Assign and track training within ComplianceWire
• Monitor training completion and follow up on overdue assignments
• Troubleshoot user/learner issues and provide system support
• Assist with maintaining curricula and course content
• Escalate system integration or configuration issues as needed

Audit & Inspection Readiness

• Retrieve and compile document and training records for audits and inspections
• Maintain records in accordance with GxP retention requirements
• Support audit preparation and remediation activities

Operational Support

• Work through document and training backlogs to maintain workflow efficiency
• Support change control processes related to documentation updates
• Ensure document control queues are up-to-date and moving forward

Qualifications

• Associate's or Bachelor's degree in life sciences or a related field
• 24 years of experience in GxP Quality Assurance or document control within pharma/biotech
• Hands-on experience with Veeva Vault QualityDocs
• Experience with ComplianceWire or similar LMS platforms
• Familiarity with 21 CFR Parts 210, 211, and 11
• Understanding of Good Documentation Practices (GDP)
• Strong attention to detail and organizational skills
• Ability to manage multiple priorities in a fast-paced environment
• Strong communication and collaboration skills

Behavioral Skills

• Curiosity: Keep on exploring uncharted territories. Always ask "why?" and more importantly "why not?",
• Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions,
• Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals,
• Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.