Senior QA Specialist, Training and Document Management

How You Will Achieve More:

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 standard.

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• Maintain controlled templates and retrieve current or historical documents and records for business needs, audits, and inspections.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.

About you:

• 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.
• 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.

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Applications are accepted on a rolling basis, and will continue to be accepted until the position is filled at which point the position will be taken down.

The salary offered is determined based on a range of factors including, but not limited to, relevant education and training, overall related experience, specialized, rare or in-demand skill sets, internal comparators and other business needs. Upon joining Intellia, your salary will be reviewed periodically and additional factors such as time in role and performance will be considered. Intellia may change the published salary range based on company and market factors.

Additional compensation includes a performance-based annual cash bonus, a new hire equity grant, and eligibility to be considered for annual equity awards the value of which are determined annually at the Company’s discretion.

For more information about Intellia’s benefits, please click here.

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