Technical Writer

High Point, North Carolina
October 20, 2026
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Job Description

Job 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.

Duties & 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.

Required Qualifications & Experience:

  • Bachelor’s degree in Chemistry, Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline required.
  • 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).
  • Experience using electronic Quality Management Systems such as Track Wise.
  • Familiarity with FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production and Current Good Manufacturing Practice regulations.

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.

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.

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