CAPA Process Analyst II

About the role

We are currently seeking a detail-oriented and experienced CAPA Specialist to support a regulated quality environment within the pharmaceutical, medical device, biotech, or laboratory space.

Key Responsibilities

• Lead and support CAPA investigations from initiation through closure
• Conduct root cause analysis for deviations, nonconformances, and quality events
• Ensure timely and compliant documentation of all quality records
• Collaborate with cross-functional teams including Quality, Manufacturing, and Regulatory
• Maintain and update records within eQMS platforms
• Support continuous improvement initiatives and audit readiness activities

Required Qualifications

• Experience working with CAPA, deviations, nonconformances, or quality investigations
• Hands-on experience with eQMS systems such as TrackWise, MasterControl, Veeva, ETQ, or similar
• Strong technical writing and documentation skills
• Bachelor’s degree in Life Sciences, Engineering, or a related field
• Experience in regulated industries (pharma, biotech, medical device, or laboratory environments)

Preferred Skills

• Knowledge of FDA, GMP, ISO, or similar regulatory standards
• Strong analytical and problem-solving abilities
• Ability to manage multiple quality records and priorities in a fast-paced environment