QC Laboratory Investigation Specialist

The Quality Control (QC) Investigation Writer / QC Laboratory Investigation Specialist is responsible for leading, authoring, and coordinating laboratory investigations within a GMP-regulated pharmaceutical, biotechnology, or biologics environment. This role ensures investigations are scientifically sound, thoroughly documented, compliant with applicable regulatory requirements, and completed within established timelines. The position collaborates with QC, Quality Assurance, Microbiology, Manufacturing, and other cross-functional teams to identify root causes, assess product impact, and develop effective corrective and preventive actions (CAPAs).

Responsibilities

• Lead and author laboratory investigations related to Out-of-Specification (OOS) results, Out-of-Trend (OOT) results, Environmental Monitoring (EM) excursions, laboratory deviations, atypical laboratory events, invalid assay results, and microbiological testing issues.
• Review and analyze laboratory data, test methods, chromatograms, worksheets, instrument records, environmental monitoring data, and supporting documentation to determine probable root causes and assess product impact.
• Facilitate investigation meetings with laboratory personnel and cross-functional stakeholders to gather facts, evaluate evidence, and establish scientifically justified conclusions.
• Perform and document root cause analyses using established investigation tools and methodologies.
• Prepare clear, concise, and comprehensive investigation reports in accordance with internal procedures, regulatory expectations, and current Good Manufacturing Practices (cGMP).
• Conduct scientific impact assessments to evaluate potential effects on product quality, patient safety, regulatory compliance, and laboratory operations.
• Author and support quality records, including deviations, Corrective and Preventive Actions (CAPAs), and Change Controls.
• Ensure investigations include appropriate corrective and preventive actions, effectiveness checks, and follow-up activities.
• Review investigation records for completeness, technical accuracy, regulatory compliance, and timely closure.
• Support Quality Assurance during investigation reviews, approvals, and resolution of documentation gaps.
• Participate in regulatory inspections, internal audits, and customer audits by providing investigation documentation and supporting responses to inquiries.
• Identify recurring laboratory issues and recommend process improvements to prevent repeat events and strengthen laboratory compliance.