Senior CAPA Associate: Root Cause & Improvement

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

Job summary

Validation & Engineering Group, Inc. in the United States is seeking a CAPA Sr.

Associate to lead investigations of nonconformances and drive CAPA initiatives within the pharmaceutical, drug manufacturing, or medical device sectors. You will develop investigation strategies, prepare technical reports, and coordinate with SMEs to implement corrective actions and ensure strict compliance with GMP and Quality Systems.

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 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 work effectively within 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, process observations, product/sample evaluations, interviews, and follow-up activities.
• Prepare clear technical reports, including investigation plans, executive summaries, testing strategies, root cause hypotheses, and investigation results.
• Apply Root Cause Analysis tools and coordinate with SMEs to obtain input.
• Support identification and implementation of mitigation actions, CAPA, and effectiveness checks.
• Partner with Investigation and CAPA approvers to support timely execution and closure of records.
• Participate in CAPA review boards and continuous improvement initiatives.
• Provide coaching, mentoring, and guidance related to Nonconformance and CAPA processes.
• Promote compliance with applicable EHS practices and a zero-harm workplace.

Skills

Quality Systems

GMP

Root Cause Analysis

CAPA

Leadership

Teamwork

English fluency

Bilingual EN/ES

Education

Bachelor's degree in Engineering/Science

Tools

TrackWise

Job description

Validation & Engineering Group, Inc. in the United States is seeking a CAPA Sr.

Associate to lead investigations of nonconformances and drive CAPA initiatives within the pharmaceutical, drug manufacturing, or medical device sectors. You will develop investigation strategies, prepare technical reports, and coordinate with SMEs to implement corrective actions and ensure strict compliance with GMP and Quality Systems.