Senior Investigator

About the role

Our client is looking for a Senior Investigator to lead and execute quality investigations within a pharmaceutical manufacturing environment. This full‑time, on‑site position focuses on thorough root cause analyses, clear documentation, and the development of corrective and preventive actions that satisfy both regulatory and internal quality standards.

Key responsibilities

• Lead complex investigations and CAPA activities across manufacturing sites.
• Conduct root cause analyses, document findings, and prepare structured investigation reports.
• Develop and implement corrective and preventive actions that meet GMP and regulatory requirements.
• Collaborate with manufacturing, quality assurance, and regulatory affairs teams to ensure timely closure of investigations.
• Drive continuous improvement of quality systems and processes.

Required profile

• Minimum 5 years of experience in pharmaceutical manufacturing, with strong knowledge of GMP and regulatory expectations.
• Bachelor’s degree in a scientific, engineering, or related field; advanced degree or relevant certifications are a plus.
• Proven ability to manage multiple quality‑related projects and coordinate cross‑functional teams.
• Excellent written and verbal communication skills for presenting findings to stakeholders.
• Must be a resident of Puerto Rico and able to work on‑site in the north region.

Required skills

• Root cause analysis methodologies
• CAPA development and implementation
• Data analysis
• Investigation reporting
• GMP knowledge
• Regulatory compliance
• Project management