Quality Document Specialist

Jobtailor; New Jersey; On-site; USD 70,000 - 110,000; Full time

Job summary

Jobtailor is seeking a QA/document-control professional to support the Quality Systems team in a pharma/biotech environment on a 6-12 month contract in New Jersey. You will manage controlled documentation and training processes to ensure GxP compliance, while supporting audit readiness activities.

You will process documents via Veeva Vault QualityDocs, manage metadata, route for reviews, and conduct periodic document reviews under senior QA guidance.

Qualifications

• Associate’s or Bachelor’s degree in life sciences or related field.
• 2–4 years of experience in GxP QA or document control within pharma/biotech.
• Hands-on experience with Veeva Vault QualityDocs.
• Experience with ComplianceWire or similar LMS.
• 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.

Responsibilities

• Support the Quality Systems team within a pharmaceutical/biotech environment for a 6-12 month contract.
• Manage controlled documentation and training processes, ensuring compliance with GxP standards.
• Support audit readiness activities.
• 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.
• Assign and track training within ComplianceWire.
• Monitor training completion and follow up on overdue assignments.
• Troubleshoot user/learner issues and provide system support.
• Maintain records in accordance with GxP retention requirements.

Skills

GxP Quality Assurance

Document Control

Training Process Management

Audit Readiness

Regulatory Compliance

Attention to Detail

Organizational Skills

Multitasking

Education

Associate’s or Bachelor’s degree in life sciences

Tools

Veeva Vault QualityDocs

ComplianceWire

Job description

• Support the Quality Systems team within a pharmaceutical/biotech environment for a 6-12 month contract
• Manage controlled documentation and training processes, ensuring compliance with GxP standards
• Support audit readiness activities
• 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
• Assign and track training within ComplianceWire
• Monitor training completion and follow up on overdue assignments
• Troubleshoot user/learner issues and provide system support
• Maintain records in accordance with GxP retention requirements

Requirements

• Associate’s or Bachelor’s degree in life sciences or a related field
• 2-4 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

Core Competencies

Demonstrates expertise in managing controlled documentation and training processes within a GxP-compliant pharmaceutical or biotech environment, with a strong focus on accuracy and regulatory adherence.

Highest-signal resume keywords

• GxP Quality Assurance
• Veeva Vault QualityDocs
• ComplianceWire
• Document Control
• Good Documentation Practices

ATS Optimization Keywords

Hard Skills

• Controlled Documentation Management
• Training Process Management
• Audit Readiness Support
• Document Metadata Management
• Periodic Document Reviews
• Troubleshooting User Issues
• Regulatory Compliance
• Document Processing
• Attention to Detail
• Organizational Skills

Soft Skills

• Ability to Manage Multiple Priorities
• Strong Communication Skills

Industry Keywords

• Pharmaceutical
• Biotech
• GxP Standards
• 21 CFR Parts 210
• 21 CFR Parts 211
• 21 CFR Part 11
• Good Documentation Practices

Tools & Technologies

• Veeva Vault QualityDocs
• ComplianceWire