Job 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 organization. This role provides technical leadership to ensure investigations are scientifically sound, timely, thorough, and compliant with current Good Manufacturing Practices (cGMP), regulatory requirements, and company procedures.

The QC Investigator partners closely with Quality Control, Quality Assurance, Manufacturing, Process Development, Engineering, and other cross-functional teams to identify root causes, assess potential product and process impact, and implement effective corrective and preventive actions (CAPAs). This position plays a critical role in maintaining product quality, ensuring regulatory compliance, and driving continuous improvement within the Quality Management System.

This is an individual contributor role with no direct reports.

Essential Job Functions

  • Lead and coordinate complex investigations involving OOS, OOT, atypical, invalid, and unexpected laboratory results.
  • Perform and/or oversee Phase I laboratory investigations and coordinate Phase II manufacturing or process investigations when required.
  • Review analytical data, laboratory notebooks, test methods, instrument data, chromatograms, calculations, and supporting documentation to ensure accurate and comprehensive investigations.
  • Apply scientific reasoning and risk-based decision-making to determine root causes and assess potential impact on product quality and patient safety.
  • Develop, document, and evaluate investigation hypotheses, ensuring appropriate testing and data assessments are completed.
  • Author, review, and approve investigation reports with clear, data-driven conclusions supported by documented evidence.
  • Identify and trend recurring laboratory, analytical, and quality issues, escalating significant concerns as appropriate.
  • Collaborate with Quality Assurance to ensure investigations are conducted and documented in accordance with GMP requirements and internal procedures.
  • Recommend and support corrective and preventive actions (CAPAs), effectiveness checks, and continuous improvement initiatives.
  • Provide technical guidance and mentorship to QC analysts and laboratory personnel regarding investigation best practices.
  • Ensure investigations are completed within established timelines and communicate progress, risks, and delays to stakeholders.
  • Participate in quality risk assessments and evaluate potential impact to batches, raw materials, finished products, stability studies, and manufacturing processes.
  • Support regulatory inspections, customer audits, and internal audits by providing investigation documentation and technical expertise.
  • Maintain current knowledge of FDA, ICH, GMP, data integrity, and industry best practices related to laboratory investigations.
  • Review laboratory procedures, analytical methods, protocols, and systems for potential investigation-related improvements.
  • Analyze investigation metrics and quality data to identify trends and opportunities to strengthen laboratory systems and processes.
  • Participate in cross-functional meetings, quality review boards, and quality governance forums as required.
  • Contribute to innovation, operational excellence, and implementation of effective quality management practices.
  • Ensure confidentiality of company, client, and product information in accordance with applicable policies and regulations.
  • Perform additional duties as assigned, consistent with the scope and responsibilities of the position.

Education

  • Bachelor's Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or a related scientific discipline required.
  • Master's Degree in a scientific discipline preferred.
  • Additional training or certifications in Quality Systems, Root Cause Analysis, Lean Six Sigma, or Pharmaceutical Manufacturing are a plus.

Experience & Skills

Experience

  • 5-8+ years of experience in Quality Control, Analytical Development, Quality Assurance, or a related GMP-regulated environment.
  • Demonstrated experience leading OOS, OOT, laboratory deviation, and atypical result investigations.
  • Experience within pharmaceutical, biotechnology, CDMO, medical device, or other regulated manufacturing environments preferred.
  • Strong experience with analytical laboratory techniques, instrumentation, and data interpretation.
  • Experience supporting regulatory inspections, customer audits, and quality compliance activities preferred.
  • Experience utilizing laboratory and quality systems, including LIMS, chromatography data systems, and electronic Quality Management Systems (eQMS), preferred.

Skills & Competencies

  • Strong understanding of current Good Manufacturing Practices (cGMP) and laboratory quality systems.
  • In-depth knowledge of OOS, OOT, investigation methodologies, and regulatory expectations.
  • Working knowledge of analytical chemistry, laboratory instrumentation, and analytical method performance.
  • Experience conducting root cause analysis using structured problem-solving methodologies and quality risk management principles.
  • Strong understanding of CAPA, deviations, change controls, and quality systems.
  • Knowledge of ALCOA+ data integrity principles and regulatory expectations.
  • Ability to interpret analytical data, statistical trends, and laboratory performance metrics.
  • Knowledge of FDA, ICH, and other applicable global regulatory requirements.
  • Strong technical writing and documentation skills.
  • Excellent analytical thinking, problem-solving, and decision-making abilities.
  • Ability to manage multiple priorities while meeting aggressive timelines.
  • Strong communication, collaboration, and stakeholder management skills.
  • Demonstrated ability to work independently and drive investigations to completion.
  • Adaptable, detail-oriented, and committed to continuous improvement.

Physical Demands

  • Ability to work in laboratory and manufacturing environments on a regular basis.
  • Ability to wear required personal protective equipment (PPE) as required.
  • Ability to sit, stand, walk, and move between laboratory, production, and office areas for extended periods.
  • Ability to review detailed analytical data, laboratory records, and technical documentation for prolonged periods.
  • Ability to occasionally lift and carry materials weighing up to 25 pounds.
  • Visual acuity sufficient to review laboratory data, instrument output, and electronic records.
  • May require occasional travel for training, audits, inspections, or business-related activities.

Annual Base Salary Range: $110,000 to $115,000

 

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