[Hiring] Senior QA Specialist @Intellia Therapeutics, Inc.

Role Description

We are 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 within a GxP-regulated environment. This role ensures audit readiness, data integrity, and strict compliance with regulatory standards.

Hands-on Veeva experience is highly preferred, but not required. This is a remote position.

Responsibilities:

• Document Control
  • Format and quality-check SOPs, work instructions, forms, and other controlled documents for compliance with approved templates, formatting standards, and document management procedures.
  • Prepare documents and records in Veeva, maintain accurate metadata and version information, and route them through established 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 in accordance with approved procedures.
  • Verify required administrative information, attachments, and approval records for completeness; 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  • Maintain controlled templates and retrieve current or historical documents and records for business needs, audits, and inspections.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 the periodic document review process.
  • 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 administrative activities.
• Training Administration
  • Administer training requirements, curricula, learner assignments, and associated records in Veeva in accordance with approved procedures.
  • Coordinate onboarding and role-change training assignments with managers and process owners.
  • Coordinate training assignments associated with 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; escalate technical or configuration issues to the designated system administrator.
  • Train GxP on documentation practices, quality standards, and system workflows.
  • Identify training gaps and coordinate with department heads to resolve compliance risks.
  • Perform onboarding of new hires in relation to their training responsibilities and introduction to Veeva.
  • Perform annual curriculum review.
  • Facilitate the escalation of and resolution for issues connected to the learning management system and/or external tools.
• Quality Support and Continuous Improvement
  • Support audit and inspections by organizing and retrieving document control and training records.
  • Identify opportunities to improve document formatting, workflow turnaround, and training administration.
  • Support approved process improvements and procedure updates.
  • Manage assigned priorities independently, communicate deadlines, and promptly escalate potential compliance concerns.
  • Compile quality metrics, track document/training KPIs, and generate reports for management review.
  • Serve as a key 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 in collaboration with system owners, IT, Validation, and business process stakeholders.
  • Participate in user acceptance testing, change control assessments, procedural updates, and training activities associated with QMS system enhancements.
  • Support the preparation of audit/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.

Qualifications

• Working knowledge of GxP documentation practices, controlled document lifecycles, training records, and data integrity principles for a commercial Quality Management System.
• Hands-on proficiency in Veeva document control and training administration, including document and record routing, metadata, training assignments, and reporting.
• Strong Microsoft Word skills, 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. No specific certification required.
• At least 5 years of relevant experience in pharmaceutical or biotechnology quality operations, document control, or training administration in a GMP environment.
• Direct, hands-on Veeva experience is highly preferred.
• Experience performing controlled document management and training administration is required.
• Experience supporting audits or inspections and improving document or training workflows is preferred.

Requirements

• This role requires prolonged periods of sitting at a desk and working on a computer.
• Occasional travel to the Cambridge, MA office may be required based on business needs.

Benefits

• The base salary for this position is expected to range between $128,986.00 - $157,650.00 USD per year.
• Additional compensation includes a performance-based annual cash bonus, a new hire equity grant, and eligibility to be considered for annual equity awards.