Position Summary The Quality Control (QC) Investigation Writer is responsible for leading, authoring, and coordinating laboratory investigations within the Quality Control department in support of GMP-regulated pharmaceutical manufacturing operations. This role serves as a subject matter expert in the investigation process and is responsible for ensuring laboratory investigations are scientifically sound, thoroughly documented, compliant with regulatory requirements, and completed within established timelines. The QC Investigation Writer partners closely with QC analysts, laboratory management, Quality Assurance, Microbiology, Manufacturing, and other cross-functional teams to investigate atypical laboratory events, identify root causes, assess product impact, and develop effective corrective and preventive actions. The position requires extensive experience with laboratory investigations including Out-of-Specification (OOS), Out-of-Trend (OOT), Environmental Monitoring (EM), and laboratory deviation investigations in an FDA-regulated GMP environment. Essential Duties and Responsibilities Lead and author Quality Control 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 and microbiological test results Data integrity and documentation discrepancies Collect, review, and analyze laboratory data, test methods, chromatograms, worksheets, instrument records, environmental monitoring data, and supporting documentation to determine probable root cause and product impact. Facilitate investigation meetings with laboratory personnel and cross-functional stakeholders to gather facts, evaluate evidence, and develop scientifically justified conclusions. Perform and document root cause analyses using established investigation tools and methodologies. Prepare clear, concise, and comprehensive investigation reports that meet internal procedures, FDA expectations, and current GMP requirements. Develop scientifically justified impact assessments to determine potential effects on product quality, patient safety, regulatory compliance, and laboratory operations. Author and support associated quality records including: Deviations Corrective and Preventive Actions (CAPAs) Change Controls Ensure investigations include appropriate corrective actions, preventive actions, effectiveness measures, and follow-up activities where required. Review investigation records for completeness, technical accuracy, regulatory compliance, and adherence to established timelines. Support Quality Assurance during investigation reviews and approvals. Participate in regulatory inspections, internal audits, and customer audits by providing investigation documentation and supporting responses to investigator inquiries. Identify recurring laboratory issues and recommend process improvements to reduce repeat events and improve laboratory compliance. Qualifications Education Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline required. Required Experience Minimum 2 years of experience in a GMP-regulated pharmaceutical, biotechnology, or biologics environment. Minimum 1 years of direct experience authoring and leading laboratory investigations within a Quality Control department (preferred) Demonstrated experience writing: OOS investigations OOT investigations Environmental Monitoring (EM) investigations Laboratory deviations CAPAs Change Controls Strong working knowledge of FDA regulations, cGMP requirements, and industry guidance related to laboratory investigations. Experience conducting scientific evaluations and root cause analyses for laboratory events. Experience reviewing analytical chemistry and/or microbiological testing data. Preferred Experience Experience using electronic Quality Management Systems such as TrackWise. Familiarity with FDA Guidance for

Industry:

Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production and Current Good Manufacturing Practice regulations. Knowledge, Skills, and Abilities Advanced technical writing and documentation skills. Strong understanding of laboratory operations, analytical testing, microbiological testing, and GMP documentation practices. Ability to critically evaluate complex laboratory data and identify scientifically defensible conclusions. Strong knowledge of investigation methodologies, root cause analysis tools, and quality risk management principles. Ability to communicate effectively with laboratory personnel, Quality Assurance, Manufacturing, and senior leadership. Excellent organizational skills with the ability to manage multiple investigations simultaneously. Strong attention to detail and commitment to data integrity and regulatory compliance. Key Competencies Technical Writing Laboratory Investigation Expertise Root Cause Analysis GMP Compliance FDA Regulatory Knowledge Quality Systems Analytical Problem Solving Cross-Functional Collaboration Risk Assessment Continuous Improvement