Senior CAPA Investigator & Quality Lead

Veg Group; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group is seeking a CAPA Sr. Associate to support nonconformance investigations, CAPA activities, root cause analyses, and documentation within a regulated pharmaceutical/medical device setting.

The role requires a Bachelor's degree in a related field, 5+ years in pharma/medical device, and 3+ years in a supervisory capacity. English fluency is essential; Spanish is a plus. Travel may be required.

Qualifications

• Bachelor’s degree in Engineering, Science, or a related field.
• Minimum 5 years of experience in pharmaceutical, drug manufacturing, or medical device industry.
• Minimum 3 years in a similar role; 5+ years preferred.
• Minimum 3 years of supervisory experience; 5+ years preferred.
• Strong knowledge of GMP; TrackWise experience preferred.
• Fluent in written and spoken English; bilingual English/Spanish.
• Ability to work 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 product/sample evaluations.
• Prepare clear technical reports with investigation plans, summaries, testing strategies, and results.
• Apply Root Cause Analysis tools and coordinate with SMEs for input.
• Support mitigation actions, 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 compliance with EHS practices and a zero-harm workplace.

Skills

Analytical

Problem-solving

Leadership

Communication

Influencing

Negotiation

Fluent English

Bilingual EN/ES

Teamwork

Education

Bachelor's degree in Engineering/Science

Tools

TrackWise

Job description

Validation & Engineering Group is seeking a CAPA Sr. Associate to support nonconformance investigations, CAPA activities, root cause analyses, and documentation within a regulated pharmaceutical/medical device setting.

The role requires a Bachelor's degree in a related field, 5+ years in pharma/medical device, and 3+ years in a supervisory capacity. English fluency is essential; Spanish is a plus. Travel may be required.