Senior CAPA Investigator & Quality Improvement Lead

Veg Group; Manatí (PR); On-site; USD 85,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a CAPA Senior Associate to lead nonconformance investigations, CAPA activities, root cause analysis, and documentation in a regulated pharma/medical device setting. This role emphasizes cross-team collaboration, reporting, and ensuring corrective actions are effective.

The candidate should have 5+ years in pharma/medical device industries, strong GMP knowledge, and supervisory experience. English fluency is required; travel may be occasional.

Qualifications

• Bachelor’s degree in Engineering, Science, or a related field.
• Minimum 5 years of experience in the pharmaceutical, drug manufacturing, or medical device industry.
• Minimum 3 years of experience in a similar role; 5+ years preferred.
• Minimum 3 years of supervisory experience; 5+ years preferred.
• Strong knowledge of Quality Systems and Good Manufacturing Practices (GMP).
• Fluent in written and spoken English; bilingual English/Spanish.
• Ability to travel occasionally.
• Physical requirements: light work, up to 20 lbs.

Responsibilities

• Execute and document nonconformance investigations, including root, probable, potential, and contributing causes.
• Develop investigation strategies through multidisciplinary collaboration and observations.
• Prepare technical reports with investigation plans, summaries, and results.
• Apply Root Cause Analysis tools and coordinate with SMEs.
• Support mitigation actions and CAPA effectiveness criteria.
• Partner with Investigation and CAPA approvers for timely closure of records.
• Participate in CAPA review boards and continuous improvement initiatives.
• Provide coaching and guidance on Nonconformance and CAPA processes.
• Promote compliance with EHS practices and a zero-harm workplace.

Skills

Analytical skills

Problem-solving

Leadership

Communication

Influencing

Negotiation

Education

Bachelor’s degree in Engineering, Science, or a related field

Tools

TrackWise

Job description

Validation & Engineering Group, Inc. seeks a CAPA Senior Associate to lead nonconformance investigations, CAPA activities, root cause analysis, and documentation in a regulated pharma/medical device setting. This role emphasizes cross-team collaboration, reporting, and ensuring corrective actions are effective.

The candidate should have 5+ years in pharma/medical device industries, strong GMP knowledge, and supervisory experience. English fluency is required; travel may be occasional.