Sr. Specialist, Quality Documents

Cabaletta Bio is in need of a Sr. Specialist, Quality Documents who will be responsible for administering and maintaining the company's document control processes and Quality Management System (QMS) documentation. This role ensures that controlled documents, records, and quality data are accurate, current, compliant, and readily accessible to support company operations and regulatory requirements. The specialist works cross-functionally to manage document workflows, record retention, and change control activities in a regulated biotechnology environment. This is an exciting time to be in this position as the company is growing and new processes are being implemented. Responsibilities: Document Control Manage the lifecycle of controlled documents, including creation, review, approval, issuance, revision, archival, and obsolescence. Assist other functional areas with the development of policies, procedures and other controlled documents. Maintain SOPs, work instructions, forms, specifications, protocols, reports, and quality records. Ensure document formatting, numbering, version control, and approval workflows comply with internal procedures. Coordinate periodic review of controlled documents. Maintain electronic document management systems (eDMS) and document repositories. Quality Management System Support Support administration of the QMS, including document control, change control, deviations, CAPAs, and quality records. Track quality system metrics and generate periodic reports. Assist in maintaining inspection and audit readiness. Support implementation and continuous improvement of quality processes. Change Control and Records Management Support document-related change control activities. Ensure quality records are complete, accurate, and retained according to company procedures and retention schedules. Coordinate archival and retrieval of records as needed. Audit and Compliance Support Assist with internal audits and external inspections. Retrieve and provide requested documentation during audits and regulatory inspections. Support remediation activities and follow-up actions related to audit findings. Qualifications: