CAPA & Investigation Lead (Pharma/Med Device)

Veg Group; Puerto Rico; On-site; USD 90,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a CAPA Sr. Associate to lead nonconformance investigations, root-cause analysis, and CAPA activities in a regulated pharmaceutical or medical device setting.

You’ll prepare technical reports, coordinate with SMEs, and help drive corrective actions while mentoring team members. You will collaborate across disciplines, promote GMP compliance, and support continuous improvement initiatives, with occasional travel.

Qualifications

• Bachelor’s degree in Engineering, Science, or a related field.
• Minimum 5 years in pharmaceutical/drug manufacturing or medical device industry; 3 years in a similar role; 5+ years preferred.
• Minimum 3 years supervisory experience; 5+ years preferred.
• Strong knowledge of Quality Systems and GMP; TrackWise experience preferred.
• Fluent in written and spoken English; bilingual English/Spanish.
• Ability to travel occasionally.
• Excellent problem-solving, communication, and leadership skills.

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, testing strategies, and root-cause hypotheses.
• Apply Root Cause Analysis tools and coordinate with SMEs for input.
• Support identification and implementation of CAPA and Effectiveness Check criteria.
• Partner with Investigation and CAPA approvers for timely closure of records.
• Participate in CAPA review boards and continuous improvement initiatives.
• Provide coaching on Nonconformance and CAPA processes; promote EHS compliance.

Skills

Analytical

Problem solving

Leadership

Communication

Negotiation

Teamwork

Bilingual English/Spanish

Travel willingness

Education

Bachelor’s degree in Engineering/Science

Tools

TrackWise

Job description

Validation & Engineering Group, Inc. seeks a CAPA Sr. Associate to lead nonconformance investigations, root-cause analysis, and CAPA activities in a regulated pharmaceutical or medical device setting.

You’ll prepare technical reports, coordinate with SMEs, and help drive corrective actions while mentoring team members. You will collaborate across disciplines, promote GMP compliance, and support continuous improvement initiatives, with occasional travel.