Senior QA Specialist, Training and Document Management

Intellia Therapeutics, Inc.•Cambridge, MA

2d•$128,986 - $157,650•Remote

About The Position

Intellia is seeking a detail-oriented Senior QA Specialist to support document control and training administration within Quality. This hands-on role oversees the lifecycle of quality documents, standard operating procedures (SOPs), and personnel training programs in a GxP-regulated environment, helping ensure audit readiness, data integrity, and compliance with regulatory standards. The position is remote. Hands-on Veeva experience is highly preferred but not required. The role administers controlled documents and training through Veeva, supports audits and inspections, tracks quality metrics, and contributes to continuous improvement of electronic document management and learning management systems. It collaborates with system owners, IT, Validation, and business process stakeholders on workflow implementation, configuration, testing, and enhancement. Occasional travel to the Cambridge, Massachusetts office may be required based on business needs.

Requirements

Working knowledge of GxP documentation practices, controlled document lifecycles, training records, and data integrity principles for a commercial Quality Management System.
Proficiency in Microsoft Word, including styles, templates, tables, section breaks, pagination, headers and footers, and tracked changes.
Proficiency in Microsoft Excel and PDF tools.
Excellent attention to detail and organizational skills.
Ability to process a high volume of documents and records accurately while managing competing deadlines.
Ability to work independently, troubleshoot routine workflow issues, and recognize when escalation is needed.
Clear communication skills and a collaborative, service-oriented approach to supporting internal users.
Bachelor’s degree in a relevant discipline, or an equivalent combination of education and directly relevant experience.
At least 5 years of relevant experience in pharmaceutical or biotechnology quality operations, document control, or training administration in a GMP environment.
Experience performing controlled document management and training administration is required.
The role requires prolonged periods of sitting at a desk and working on a computer.

Nice To Haves

Hands-on proficiency in Veeva document control and training administration, including document and record routing, metadata, training assignments, and reporting.
Direct, hands-on Veeva experience.
Experience supporting audits or inspections and improving document or training workflows.

Responsibilities

Format and quality-check SOPs, work instructions, forms, and other controlled documents against approved templates, formatting standards, and document management procedures.
Prepare documents and records in Veeva, maintain metadata and version information, and route items through review and approval workflows.
Coordinate with authors, reviewers, and approvers to resolve administrative issues and follow up on outstanding workflow tasks.
Process document issuance, effective dates, periodic reviews, revisions, obsolescence, and archival according to approved procedures.
Verify administrative information, attachments, and approval records for completeness, and escalate discrepancies to the appropriate owner.
Maintain controlled templates and retrieve current or historical documents and records for business needs, audits, and inspections.
Track and manage periodic document reviews; improve documentation access and controls.
Develop, document, and update quality policies, procedures, and work instructions.
Identify opportunities to streamline document lifecycle management, improve electronic workflow efficiency, and reduce manual administration.
Administer training requirements, curricula, learner assignments, and associated records in Veeva according to approved procedures.
Coordinate onboarding and role-change training assignments with managers and process owners.
Coordinate training assignments for new or revised controlled documents.
Monitor training completion, issue reminders, follow up on overdue assignments, and escalate unresolved gaps.
Maintain training completion records and generate training status reports and metrics.
Provide routine user support for document and training workflows, escalating technical or configuration issues to the designated system administrator.
Train GxP personnel on documentation practices, quality standards, and system workflows.
Identify training gaps and coordinate with department heads to resolve compliance risks; onboard new hires regarding training responsibilities and Veeva.
Perform annual curriculum reviews.
Facilitate escalation and resolution of issues involving the learning management system and/or external tools.
Support audits and inspections by organizing and retrieving document control and training records.
Support approved process improvements and procedure updates, and identify improvements to document formatting, workflow turnaround, and training administration.
Manage assigned priorities independently, communicate deadlines, and promptly escalate potential compliance concerns.
Compile quality metrics, track document and training KPIs, and generate reports for management review.
Serve as a Quality Systems resource for administration, maintenance, and continuous improvement of electronic document management and LMS platforms within Veeva.
Support implementation, configuration, testing, and enhancement of electronic Quality Systems workflows with system owners, IT, Validation, and business process stakeholders.
Participate in user acceptance testing, change control assessments, procedural updates, and training activities related to QMS system enhancements.
Support preparation of audit and inspection responses, investigation documentation, and CAPA commitments related to assigned Quality Systems processes.
Promote a proactive culture of regulatory compliance, inspection readiness, and continuous improvement.