Job Description

Overview of Position

The Quality Systems Specialist is responsible for supporting the Quality Management System (QMS), including GxP document management and training programs. This role ensures compliance with regulatory standards, maintains the integrity of documentation systems, and collaborates with cross-functional teams to support document and training needs.

Essential Duties

GxP Document Management

• Collaborate cross-functionally to generate workflow status reports and support document owners with new document creation and revisions.
• Review procedural documents for compliance with formatting, metadata, and applicable standards.
• Initiate periodic review workflows.
• Serve as workflow owner as needed.
• Assist document owners in ensuring proper GxP records management.
• Create document reports to support business processes, including periodic review and stagnant draft reports.
• Generate document owner, workflow owner, and task owner reports to support offboarding activities and transfer ownership as appropriate.

Training Program Support

• Generate training reports and distribute upcoming and overdue training notifications.
• Initiate training assessment forms for managers of new personnel.
• Create learner roles, training requirements, and curricula within the training management system.

Quality Management System Support

• Schedule and facilitate initial and status meetings.
• Route forms for electronic signature and maintain tracking logs.
• Upload completed forms into the document management system.

Audits and Inspections

• Prepare for and participate in internal and external audits related to document control and quality systems.

Skills & Education Requirements

• Bachelor’s degree in Life Sciences or a related field, or an Associate degree with relevant work experience.
• Minimum of 5 years of document control experience.
• Proficiency with electronic document management systems (e.g., Veeva QualityDocs).
• Experience supporting gene and cell therapy products.
• Prior experience in a startup or fast-paced environment.
• Demonstrated integrity, accountability, and strong teamwork skills.

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