Quality Document Specialist

DescriptionWe 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 remotePay Rate: $55-$70 /hrKey ResponsibilitiesDocument Control & Veeva Vault QualityDocsProcess controlled documents (SOPs, Work Instructions, forms) through the Veeva Vault QualityDocs workflowManage document metadata and ensure accuracy and completenessRoute documents for review and approval in accordance with established proceduresExecute periodic document reviews under the guidance of senior QA staffTraining Management (ComplianceWire)Assign and track training within ComplianceWireMonitor training completion and follow up on overdue assignmentsTroubleshoot user/learner issues and provide system supportAssist with maintaining curricula and course contentEscalate system integration or configuration issues as neededAudit & Inspection ReadinessRetrieve and compile document and training records for audits and inspectionsMaintain records in accordance with GxP retention requirementsSupport audit preparation and remediation activitiesOperational SupportWork through document and training backlogs to maintain workflow efficiencySupport change control processes related to documentation updatesEnsure document control queues are up-to-date and moving forwardQualificationsAssociate’s or Bachelor’s degree in life sciences or a related field2–4 years of experience in GxP Quality Assurance or document control within pharma/biotechHands-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 skillsBehavioral SkillsCuriosity: 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.DBV Technologies is a global clinical stage biopharmaceutical company founded by pediatricians who believed that food allergies could one day be treated safely and effectively.We are on a mission to advance epicutaneous immunotherapy using our innovative technology platform, Viaskin™, to develop treatment options for immunologic diseases with significant unmet medical need.This mission drives our commitment to the advancement of treatments for patients and their families. That is why we are investigating a potential new class of immunotherapy, epicutaneous immunotherapy (EPIT), that aims to re-educate the immune system of patients through the skin.Today, we are focused on exploring the use of Viaskin to address food allergies, a devastating condition that afflicts millions of patients. As an important milestone in our journey, we hope to offer the first epicutaneous immunotherapy treatment for peanut allergy.Tomorrow, as pioneers, we will continue to explore the broad applications of this potential new class of immunotherapy, including treatments for patients suffering from inflammatory and autoimmune diseases.