CAPA & Quality Investigations Specialist

Veg Group; Aibonito (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

Pinnaql is a trusted consulting partner to regulated life sciences companies, delivering CAPA execution, quality investigations, and robust documentation.

The CAPA Specialist will support investigation activities, perform root cause analysis, develop corrective actions, and maintain accurate CAPA records while collaborating with QA, manufacturing, and engineering onsite in Puerto Rico.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, or a related discipline.
• At least 3 years of relevant experience supporting CAPA activities, quality investigations, or quality systems within a regulated manufacturing environment.
• Working knowledge of root cause analysis, nonconformance investigations, and CAPA processes.
• Experience with regulated quality systems and familiarity with applicable industry standards is highly desirable.

Responsibilities

• Execute activities associated with CAPA records and quality investigations, including gathering information, reviewing documentation, and documenting findings.
• Conduct root cause analysis to identify the underlying causes of deviations, nonconformances, and other quality issues.
• Support the identification, definition, and implementation of corrective and preventive actions.
• Prepare and maintain accurate investigation reports, CAPA documentation, and supporting quality records.
• Assist with follow‑up activities to verify action implementation and document effectiveness checks, as applicable.
• Collaborate with Quality Assurance, Manufacturing, Engineering, and other cross‑functional teams to support timely completion of assigned activities.
• Ensure work is performed in accordance with established procedures, quality system requirements, and applicable regulatory expectations.

Skills

CAPA processes

Root cause analysis

Documentation

Communication

Education

Bachelor's degree in Engineering/Life Sciences/Chemistry

Job description

Pinnaql is a trusted consulting partner to regulated life sciences companies, delivering CAPA execution, quality investigations, and robust documentation.

The CAPA Specialist will support investigation activities, perform root cause analysis, develop corrective actions, and maintain accurate CAPA records while collaborating with QA, manufacturing, and engineering onsite in Puerto Rico.