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Quality Applications Specialist
Cabaletta Bio. Administer and maintain eQMS software applications and related technologies .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in administering eQMS software applications, ensuring compliance with FDA regulations and quality standards. Proficient in managing system access, performing validation activities, and enhancing business processes through automation and efficiency improvements.
Highest-signal resume keywords
EQMS AdministrationFDA 21 CFR Part 11 ComplianceQuality Management Systems SupportProject Management SkillsRegulated Industry Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Workflow ConfigurationSystem MonitoringUser Acceptance TestingData Integrity ManagementValidation DocumentationAutomation AnalysisIssue ResolutionChange ControlTraining DevelopmentDocumentation Management
Soft Skills
Excellent Organizational SkillsStrong Written CommunicationStrong Verbal CommunicationAbility to Manage Multiple PrioritiesCollaborative Work Style
Tools & Technologies
ZenQMSVeeva Quality Vault
Industry Keywords
GxP RequirementsISO 9001ISO 13485GCPGMPGLPAudit ReadinessInspection ReadinessBiotechnologyPharmaceutical Operations
Tech Stack
Tools & technologiesGoogle Cloud PlatformVault
About the role
Key responsibilities & impact- Administer and maintain eQMS software applications and related technologies
- Configure workflows, forms, notifications, templates, reports, and user roles
- Manage system access, permissions, and security
- Perform routine system monitoring and health checks
- Coordinate software upgrades, patches, and releases
- Partner with stakeholders to translate business requirements into system solutions
- Support end users with issue resolution, troubleshooting, and system guidance
- Analyze business processes and identify automation and efficiency improvements
- Recommend enhancements improving usability, compliance, and data integrity
- Support computerized system validation activities and maintain validation documentation
- Ensure systems comply with FDA 21 CFR Part 11, EU Annex 11, GxP requirements, ISO 9001, ISO 13485 if applicable, and company quality standards
- Support system change control, impact assessments, testing, user acceptance, documentation, and approvals
- Serve as primary contact for QMS software vendors
- Coordinate issue resolution and enhancement requests
- Collaborate with Quality Assurance, Regulatory Affairs, Manufacturing Operations, IT, Learning & Development, Compliance, and other stakeholders
- Develop and maintain system procedures, work instructions, and user guides
- Deliver end-user training and support programs
- Maintain training materials and reference documentation
- Support inspection and audit readiness
- Participate in QMS transformation initiatives
- Support implementation of new QMS modules and technologies
- Stay current on industry best practices and emerging quality technologies
Requirements
What you’ll need- 3-7 years of experience supporting Quality Management Systems or enterprise applications
- Experience working in regulated industries preferred
- Experience administering eQMS platforms such as ZenQMS and Veeva Quality Vault preferred
- Associate or Bachelor degree in Life Sciences, Biotechnology, Quality Assurance, or a related field preferred
- Knowledge of 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
- Ability to work independently and collaboratively in a fast-paced environment
- Knowledge of 21 CFR Part 11 electronic records and electronic signatures requirements
- Experience supporting FDA-regulated biotechnology or pharmaceutical operations preferred
- Project management skills
- Must maintain accurate and compliant documentation
- Must support audit and inspection readiness through effective document management
Benefits
Comp & perks- Competitive benefits
- PTO
- Stock option plans
- Commitment to employee well-being and continuous growth
- Great Place to Work-Certified™ company