Investigation 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:

• 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:

• 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)

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