Senior CAPA Investigator & Quality Systems Leader

Validation & Engineering Group, Inc.; Barceloneta (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. in the United States seeks a CAPA Sr. Associate to lead nonconformance investigations and drive CAPA execution in pharma, biotech, and medical devices.

You will document root causes, develop strategies, and coordinate with SMEs to ensure robust corrective actions. Responsibilities include preparing technical reports, applying RCA tools, and mentoring teams while promoting GMP adherence and a strong quality system.

Qualifications

• Bachelor’s degree in Engineering, Science, or related field.
• Minimum 5 years in pharma/drug manufacturing or medical device industry.
• Minimum 3 years supervisory experience; 5+ years preferred.
• Strong GMP knowledge; TrackWise experience preferred.
• Fluent in written and spoken English; bilingual English/Spanish.
• Ability to work effectively in multidisciplinary teams.
• Willingness to travel occasionally.

Responsibilities

• Execute and document nonconformance investigations, including root, probable, potential, and contributing causes.
• Develop investigation strategies through multidisciplinary collaboration and observations.
• Prepare clear technical reports with investigation plans, summaries, and results.
• Apply Root Cause Analysis tools and coordinate with SMEs for input.
• Support mitigation actions, CAPA, and effectiveness checks.
• 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 related field

Tools

TrackWise

Job description

Validation & Engineering Group, Inc. in the United States seeks a CAPA Sr. Associate to lead nonconformance investigations and drive CAPA execution in pharma, biotech, and medical devices.

You will document root causes, develop strategies, and coordinate with SMEs to ensure robust corrective actions. Responsibilities include preparing technical reports, applying RCA tools, and mentoring teams while promoting GMP adherence and a strong quality system.