Senior Specialist, Quality Documents

About the role

Cabaletta Bio is looking for a Senior Specialist, Quality Documents to administer and maintain its document control processes and Quality Management System (QMS) documentation. The specialist ensures controlled documents, records and quality data are accurate, current, compliant and accessible, and works cross-functionally on document workflows, record retention and change control in a regulated biotechnology environment. The position is hybrid and based in Philadelphia, PA.

Key responsibilities

• Manage the lifecycle of controlled documents: creation, review, approval, issuance, revision, archival and obsolescence
• Maintain SOPs, work instructions, forms, specifications, protocols, reports and quality records, and ensure formatting, numbering, version control and approval workflows comply with internal procedures
• Maintain electronic document management systems (eDMS) and document repositories
• Support 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 and support continuous improvement of quality processes
• Ensure quality records are complete, accurate and retained according to retention schedules, and coordinate archival and retrieval of records
• Assist with internal audits and external inspections, retrieve requested documentation and support remediation of audit findings

Required profile

• 7-10 years of experience in document control, quality assurance or quality systems within biotech, pharmaceutical, medical device or a regulated industry
• Associate's or Bachelor's degree in Life Sciences, Biotechnology, Quality Assurance or a related field preferred
• Excellent organizational skills, attention to detail, ability to manage multiple priorities and deadlines, and strong written and verbal communication
• Ability to work independently and collaboratively in a fast-paced environment

Required skills

• Experience with eDMS such as ZenQMS and Veeva Quality Vault
• Proficiency with Microsoft Office, especially Word, Excel and SharePoint
• Knowledge of GxP, GCP, GMP, GLP preferred; experience with quality management software (qEIMS) preferred
• Preferred: experience with FDA-regulated operations, knowledge of 21 CFR Part 11, and audit and inspection readiness

What we offer

• Health and retirement benefits
• PTO
• Stock option plans