Position Title: Sr. Specialist, Quality DocumentsLocation: Hybrid/Philadelphia, PA About the Position: 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.
Required Qualifications: - 7-10 years of experience in document control, quality assurance, or quality systems within a biotech, pharmaceutical, medical device, or regulated industry.
- Associate's or Bachelor's degree in Life Sciences, Biotechnology, Quality Assurance, or a related field preferred.
- Experience working with electronic document management systems (eDMS) such as ZenQMS and Veeva Quality Vault.
- Knowledge of GxP, GCP, GMP, GLP preferred.
- Excellent organizational skills and attention to detail.
- Ability to manage multiple priorities and meet deadlines.
- Strong written and verbal communication skills.
- Proficiency with Microsoft Office applications, particularly Word, Excel, and SharePoint.
- Experience with quality management software (eQMS) preferred.
- Ability to work independently and collaboratively in a fast-paced environment.
Preferred Qualifications: - Experience supporting FDA-regulated biotechnology or pharmaceutical operations.
- Knowledge of 21 CFR Part 11 electronic records and electronic signatures requirements.
- Maintains accurate and compliant documentation.
- Demonstrates strong customer service and responsiveness to internal stakeholders.
- Contributes to a culture of quality and continuous improvement.
- Supports audit and inspection readiness through effective document management.
Our name - Cabaletta - is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression.
For more information, please visit https://www.cabalettabio.com/join-our-crew
Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans.
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