Lead Investigator – Manufacturing Investigations

About the role

The Lead Investigator will drive quality event investigations across sterile and non‑sterile pharmaceutical manufacturing sites in northern Puerto Rico. Working onsite, you will partner with cross‑functional teams to ensure investigations are completed on time, support regulatory submissions, and contribute to continuous improvement initiatives.

Key responsibilities

• Execute and manage quality event investigations within established timelines.
• Document, close, and report investigations, ensuring compliance with cGMP, OSHA, EPA, and other regulatory requirements.
• Lead CAPA trend analyses to identify recurring issues and improvement opportunities.
• Analyze investigation data and provide actionable recommendations.
• Prepare clear, technically sound investigation reports for regulatory submissions.
• Support regulatory inspections by providing investigation‑related documentation.
• Collaborate with Manufacturing, Quality, Engineering, and other teams to determine root causes and implement corrective actions.

Required profile

• Bachelor’s degree in Science, Pharmacy, Engineering, or a related field.
• Minimum 5 years of experience in a parenteral manufacturing environment.
• At least 1 year of direct experience conducting investigations.
• Strong technical writing, documentation, presentation, and communication skills.
• Fluent in both Spanish and English.

Required skills

• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint