IR
Technical Writer
Integrated Resources, Inc
- 🇺🇸 United States
- On-site
- 22 hours ago
- GMP
- Regulatory Compliance
- Technical Writing
- Risk Management
22 hours ago
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.
- 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.
- 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)
- 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.
- 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.
- 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
Technical Writer · Integrated Resources, Inc