Senior Quality Documents Specialist — QMS & Records

Cabaletta Bio; Philadelphia (Philadelphia County); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Stock options

Competitive benefits

Paid time off

Job summary

Cabaletta Bio is seeking a Sr. Specialist, Quality Documents to oversee document control and QMS documentation within our regulated environment. The role collaborates across functions to ensure accurate records, compliant workflows, and timely updates.

Responsibilities include supporting change control, CAPAs, and audits, with an emphasis on maintaining file integrity and archival processes in a fast-paced biotech setting.

Qualifications

• 7–10 years in document control/quality systems within biotech or regulated industries.
• Experience with eDMS and controlled document lifecycle.
• Familiarity with GxP, GCP, GMP, GLP preferred.

Responsibilities

• Administer and maintain document control processes and QMS documentation.
• Support change control, deviations, CAPAs, and quality records.
• Assist with audits, inspections, and readiness activities.

Skills

Document control

Quality systems

eDMS experience

GxP/GMP knowledge

Communication

Education

Bachelor's or Associate degree in Life Sciences or related field

Tools

ZenQMS

Veeva Quality Vault

eQMS

Job description

Cabaletta Bio is seeking a Sr. Specialist, Quality Documents to oversee document control and QMS documentation within our regulated environment. The role collaborates across functions to ensure accurate records, compliant workflows, and timely updates.

Responsibilities include supporting change control, CAPAs, and audits, with an emphasis on maintaining file integrity and archival processes in a fast-paced biotech setting.