Senior CAPA Associate: Pharma/Med Device Quality Lead

Veg Group; Carolina (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a CAPA Sr. Associate to lead nonconformance investigations, identify root, probable, and contributing causes, and document findings in a regulated pharmaceutical or medical device environment.

You will develop investigation strategies through multidisciplinary collaboration, prepare technical reports and summaries, apply RCA tools with SMEs, support CAPA actions and effectiveness checks, and coach teams to ensure GMP compliance.

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; 3 years in a similar role; 5+ years preferred.
• Minimum 3 years of supervisory experience; 5+ years preferred.
• Strong knowledge of Quality Systems and GMP; TrackWise experience preferred.
• Strong analytical, problem-solving, leadership, communication, influencing, and negotiation skills.
• Fluent in written and spoken English; bilingual English/Spanish.
• Ability to travel occasionally.
• Light work physically, up to 20 lbs; manufacturing setting exposure.

Responsibilities

• Execute and document nonconformance investigations, identifying root and contributing causes.
• Develop investigation strategies through multidisciplinary collaboration, observations, testing, interviews, and follow-up activities.
• Prepare clear technical reports including investigation plans, executive summaries, testing strategies, root cause hypotheses, and results.
• Apply Root Cause Analysis tools and coordinate with SMEs for input.
• Support identification and implementation of corrective and preventive actions and effectiveness checks.
• Partner with Investigation and CAPA approvers to ensure timely execution and closure of records.
• Participate in CAPA review boards and continuous improvement initiatives.
• Provide coaching and guidance related to Nonconformance and CAPA processes.
• Promote compliance with applicable EHS practices and a zero-harm workplace.

Skills

Root Cause Analysis

CAPA investigations

Quality Systems

GMP

Leadership

Communication

Problem solving

Teamwork

Education

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

Tools

TrackWise

Job description

Validation & Engineering Group, Inc. seeks a CAPA Sr. Associate to lead nonconformance investigations, identify root, probable, and contributing causes, and document findings in a regulated pharmaceutical or medical device environment.

You will develop investigation strategies through multidisciplinary collaboration, prepare technical reports and summaries, apply RCA tools with SMEs, support CAPA actions and effectiveness checks, and coach teams to ensure GMP compliance.