Laboratory Investigator

Title: Laboratory Investigator (Regulated Industry)

Location: North East of Puerto Rico

100% onsite work

Period: Approximately 6 months contract

The Laboratory Investigator is responsible for supporting quality and analytical operations by conducting thorough investigations related to laboratory deviations, out-of-specification (OOS) results, out-of-trend (OOT) data, invalid tests, and other quality events. This role ensures that all investigations are performed in full compliance with regulatory standards, internal procedures, and current Good Manufacturing Practices (cGMP).

Key Responsibilities

• Conduct detailed laboratory investigations, including root cause analysis, data review, and assessment of analytical test performance.
• Review laboratory documentation, raw data, chromatographic results, sample preparation records, and instrument logs to ensure accuracy, completeness, and data integrity.
• Collaborate with cross-functional teams such as Quality Control, Quality Assurance, Manufacturing, and Technical Services to gather information and determine appropriate corrective actions.
• Prepare investigation reports, ensuring clarity, scientific justification, and compliance with internal quality standards and regulatory requirements.
• Perform impact assessments to evaluate potential product quality implications and ensure timely resolution of all assigned investigations.
• Evaluate analytical methods, equipment performance, and laboratory practices to identify potential gaps and recommend preventive actions.
• Support continuous improvement initiatives by identifying trends, proposing procedural updates, and contributing to quality system enhancements.
• Ensure all investigative activities are documented accurately and completed within established timelines to maintain audit readiness.
• Assist laboratory personnel by providing guidance on proper documentation practices, cGMP compliance, and investigation expectations.
• Participate in audits and inspections by providing supporting documentation and subject-matter expertise regarding laboratory operations and investigations.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Microbiology, or a related scientific field.
• Experience working in a cGMP-regulated laboratory environment.
• Strong understanding of analytical techniques, laboratory instruments, and quality systems.
• Excellent analytical thinking, problem-solving capabilities, and attention to detail.
• Strong written and verbal communication skills, with the ability to prepare well-structured investigation reports.
• Ability to manage multiple priorities, meet tight deadlines, and collaborate effectively across departments.

This role is essential in maintaining the integrity of laboratory data, ensuring regulatory compliance, and upholding the quality standards required for product release and patient safety.

If you are ready to join our network of professionals apply inside the job description link with an updated resume.