Title: Lead Investigator – Manufacturing Investigations

Location: North of Puerto Rico (Open only for Puerto Rico Residents)

Onside work

Position Overview

Our Client is seeking for Lead Investigators to support for manufacturing investigations across sterile and non-sterile operations.

The selected professionals will be responsible for executing and managing quality event investigations, supporting regulatory submissions, and leading trend evaluations to promote compliance, product quality, and continuous improvement within the manufacturing environment.

This role will work closely with cross-functional teams and provide technical and scientific support for manufacturing initiatives and regulatory inspection activities, as needed.

Qualifications

• Bachelor’s degree in Science, Pharmacy, Engineering, or a related field.
• Minimum of 5 years of experience in a parenteral manufacturing environment.
• At least 1 year of direct experience with investigations.
• Strong technical writing and documentation skills.
• Strong presentation and communication skills.
• Proficiency in Microsoft Office, including Word, Excel, and PowerPoint.
• Working knowledge of cGMPs, OSHA, EPA, and applicable regulatory requirements.
• Excellent communication skills in both Spanish and English.
• Ability to work effectively in a team environment and collaborate with cross-functional groups.

Key Responsibilities

• Execute and manage quality event investigations within established timelines.
• Ensure quality events, including applicable notifications and related records, are properly investigated, documented, and closed on time.
• Lead quality event and CAPA trend evaluations to identify recurring issues and opportunities for improvement.
• Analyze investigation data and provide recommendations based on findings.
• Prepare clear, accurate, and technically sound investigation documentation.
• Support regulatory submissions associated with manufacturing investigations and quality events.
• Participate in regulatory inspections and provide investigation-related support, as needed.
• Collaborate with Manufacturing, Quality, Engineering, and other cross-functional teams to identify root causes and implement appropriate corrective actions.
• Support site initiatives related to manufacturing compliance, quality, and continuous improvement.
• Apply applicable regulatory and quality requirements when evaluating manufacturing events.

Manufacturing Environment

The role will support manufacturing activities across sterile and non-sterile operations. Candidates should be comfortable working in a regulated pharmaceutical manufacturing environment and applying investigation methodologies to manufacturing-related quality events.

Tools & Systems

The position requires proficiency with standard Microsoft Office applications, particularly:

• Microsoft Word – technical documentation and investigation reports
• Microsoft Excel – data analysis and trending
• Microsoft PowerPoint – presentations and communication of investigation findings

Critical Success Factors

Success in this role will require the ability to:

• Effectively lead and manage manufacturing investigations from initiation through closure.
• Meet established timelines for quality events and corrective actions.
• Perform thorough data analysis and identify meaningful trends.
• Produce high-quality technical documentation.
• Apply sound investigation and root-cause analysis practices.
• Demonstrate a strong understanding of cGMP and applicable regulatory requirements.
• Communicate effectively with cross-functional teams in English and Spanish.
• Work independently while maintaining strong collaboration with internal stakeholders.
• Support a culture of compliance, quality, and continuous improvement.