Technical Writer

Job Title: Quality Control Investigation Writer

Location: High Point, NC 27265

Duration: 12 Months - Contract

Pay Rate: $20.00 - $36.00/hr w2

Position Summary:

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• 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.
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• 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.
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• 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.
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• 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.
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Essential Duties and Responsibilities:

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• Lead and author Quality Control laboratory investigations related to:
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• Out-of-Specification (OOS) results
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• Out-of-Trend (OOT) results
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• Environmental Monitoring (EM) excursions
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• Laboratory deviations
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• Atypical laboratory events
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• Invalid assay and microbiological test results
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• Data integrity and documentation discrepancies
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• 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.
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• Facilitate investigation meetings with laboratory personnel and cross-functional stakeholders to gather facts, evaluate evidence, and develop scientifically justified conclusions.
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• Perform and document root cause analyses using established investigation tools and methodologies.
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• Prepare clear, concise, and comprehensive investigation reports that meet internal procedures, FDA expectations, and current GMP requirements.
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• Develop scientifically justified impact assessments to determine potential effects on product quality, patient safety, regulatory compliance, and laboratory operations.
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• Author and support associated quality records including:
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• Deviations
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• Corrective and Preventive Actions (CAPAs)
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• Change Controls
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• Ensure investigations include appropriate corrective actions, preventive actions, effectiveness measures, and follow-up activities where required.
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• Review investigation records for completeness, technical accuracy, regulatory compliance, and adherence to established timelines.
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• Support Quality Assurance during investigation reviews and approvals.
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• Participate in regulatory inspections, internal audits, and customer audits by providing investigation documentation and supporting responses to investigator inquiries.
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• Identify recurring laboratory issues and recommend process improvements to reduce repeat events and improve laboratory compliance.
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Qualifications:

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• Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline required.
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• Minimum 2 years of experience in a GMP-regulated pharmaceutical, biotechnology, or biologics environment.
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• Minimum 1 years of direct experience authoring and leading laboratory investigations within a Quality Control department (preferred)
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Demonstrated experience writing:

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• OOS investigations
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• OOT investigations
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• Environmental Monitoring (EM) investigations
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• Laboratory deviations
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• CAPAs
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• Change Controls
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• Strong working knowledge of FDA regulations, cGMP requirements, and industry guidance related to laboratory investigations.
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• Experience conducting scientific evaluations and root cause analyses for laboratory events.
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• Experience reviewing analytical chemistry and/or microbiological testing data.
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Preferred Experience:

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• Experience using electronic Quality Management Systems such as TrackWise.
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• Familiarity with FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production and Current Good Manufacturing Practice regulations.
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Knowledge, Skills, and Abilities:

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• Advanced technical writing and documentation skills.
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• Strong understanding of laboratory operations, analytical testing, microbiological testing, and GMP documentation practices.
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• Ability to critically evaluate complex laboratory data and identify scientifically defensible conclusions.
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• Strong knowledge of investigation methodologies, root cause analysis tools, and quality risk management principles.
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• Ability to communicate effectively with laboratory personnel, Quality Assurance, Manufacturing, and senior leadership.
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• Excellent organizational skills with the ability to manage multiple investigations simultaneously.
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• Strong attention to detail and commitment to data integrity and regulatory compliance.
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Key Competencies:

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• Technical Writing
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• Laboratory Investigation Expertise
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• Root Cause Analysis
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• GMP Compliance
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• FDA Regulatory Knowledge
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• Quality Systems
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• Analytical Problem Solving
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• Cross-Functional Collaboration
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• Risk Assessment
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• Continuous Improvement
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