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 #J-18808-Ljbffr DBV Technologies