Technical Writer

Technical Writer | High Point, North Carolina, United States Technical Writer - Quality Control Investigation Writer (GMP, Pharma) Location: High Point, NC 27265 | Contract | 2-5 Years Experience About the Role Join a dynamic pharmaceutical Quality Control team as a QC Investigation Writer, where your technical writing expertise will drive compliance and contribute directly to patient safety. You'll be at the forefront of laboratory investigations, collaborating cross-functionally to ensure data integrity and regulatory excellence in a fast-paced, growth-oriented environment. Responsibilities - Lead, author, and coordinate complex laboratory investigations (OOS, OOT, EM, deviations) to support GMP manufacturing operations. - Analyze laboratory data, test methods, instrument records, and documentation to determine root causes and product impact. - Facilitate investigation meetings with QC analysts, Microbiology, QA, and Manufacturing to gather facts and reach scientifically sound conclusions. - Prepare clear, concise, and comprehensive investigation reports aligned with FDA and cGMP standards. - Develop and document corrective/preventive actions (CAPAs), change controls, and impact assessments. - Review quality records for accuracy, completeness, and timely completion, supporting internal/external audits and regulatory inspections. - Identify and recommend process improvements to enhance laboratory compliance and reduce repeat events. Required Skills and Experience - Bachelor's in Chemistry, Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or related discipline. - 2+ years' experience in GMP-regulated pharmaceutical, biotech, or biologics environment. - 1+ year direct experience authoring and leading QC laboratory investigations. - Advanced technical writing and documentation skills. - Strong knowledge of FDA regulations, cGMP requirements, and laboratory investigation best practices. - Demonstrated expertise in root cause analysis, analytical problem solving, and scientific evaluation of laboratory data. Preferred Skills - Experience with electronic Quality Management Systems (e.g., TrackWise). - Familiarity with FDA OOS Guidance and current Good Manufacturing Practice regulations. - Experience reviewing analytical chemistry and/or microbiological testing data. Benefits - Exposure to high-impact, cross-functional projects in a leading GMP environment. - Opportunity to work alongside industry experts and further develop technical writing and investigation leadership skills. - Gain hands-on experience supporting regulatory inspections and audits. - Supportive culture focused on continuous improvement and professional growth. How to Apply Take the next step in your quality and compliance career! Submit your resume detailing relevant technical writing and QC investigation experience.