Quality Document Specialist

Description:

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:

Document Control & Veeva Vault QualityDocs

• 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

• 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

• 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.