Work Location: Middlesex County, Massachusetts

Summary:

The QC Investigator is responsible for leading and coordinating laboratory investigations related to Out-of-Specification (OOS), Out-of-Trend (OOT), atypical results, laboratory deviations, and other quality events within the Quality Control (QC) organization. This role ensures investigations are scientifically sound, timely, thorough, and compliant with applicable GMP requirements and procedures, while collaborating with cross-functional teams to identify root causes, assess impact, and implement corrective and preventive actions.

Responsibilities:

• Lead and coordinate investigations for OOS, OOT, atypical, invalid, and unexpected laboratory results, ensuring scientific rigor and compliance.
• Review analytical data, laboratory records, test methods, instrument data, and supporting documentation to support investigations.
• Apply scientific and risk-based approaches to determine root causes and assess potential product and process impact.
• Develop investigation hypotheses, ensure appropriate testing or data review, and author clear, evidence-based reports.
• Identify and escalate trends or recurring laboratory and analytical issues, supporting continuous improvement initiatives.
• Collaborate with cross-functional teams to recommend and support corrective and preventive actions (CAPA) and effectiveness checks.
• Provide technical guidance and mentoring to QC analysts and investigators, ensuring investigations are completed within established timelines.
• Support regulatory inspections and audits by providing investigation documentation and technical explanations, while maintaining awareness of applicable regulatory and quality requirements.

Qualifications:

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or a related scientific discipline required; Master’s degree preferred.
• 5–8+ years of experience in QC, analytical laboratory, QA, or a related GMP-regulated environment.
• Demonstrated experience leading OOS, OOT, deviation, and laboratory investigations.
• Experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments preferred.
• Strong experience with analytical laboratory techniques, data interpretation, and laboratory systems such as LIMS and chromatography data systems preferred.
• Comprehensive understanding of GMP, laboratory quality systems, OOS/OOT investigation principles, and regulatory expectations.
• Familiarity with root-cause analysis, quality risk management tools, CAPA, deviations, change controls, and laboratory data integrity (including ALCOA+ principles).
• Ability to interpret statistical and analytical trends, evaluate laboratory data, and understand FDA, ICH, and other regulatory requirements.

Published Category: Quality & Validation