Technical Writer

Title: QC Investigation Writer / Technical Writer – GMP | OOS/OOT Investigations

Job Summary:

• Responsible for leading and authoring laboratory investigations in a GMP-regulated pharmaceutical environment.
• Investigate OOS/OOT results, environmental monitoring excursions, laboratory deviations, invalid test results, and data integrity issues. Perform root cause analysis, assess product impact, and prepare scientifically sound investigation reports in compliance with FDA and cGMP requirements.

Key Responsibilities:

• Lead and document OOS/OOT, laboratory deviation, and environmental monitoring investigations.
• Analyze laboratory data, analytical testing results, and supporting documentation to identify root causes.
• Prepare investigation reports, CAPAs, deviations, and change controls.
• Conduct product impact assessments and recommend corrective and preventive actions.
• Collaborate with QC, QA, Microbiology, and Manufacturing teams.
• Ensure data integrity, regulatory compliance, and timely investigation closure.
• Support audits, regulatory inspections, and continuous improvement initiatives.

Required Qualifications:

• Bachelor’s degree in Chemistry, Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related field.
• Minimum 2 years of experience in a GMP-regulated pharmaceutical, biotechnology, or biologics environment.
• Experience authoring laboratory investigations, including OOS/OOT, deviations, and CAPAs.
• Strong knowledge of FDA regulations, cGMP, root cause analysis, and laboratory documentation.
• Ability to review analytical chemistry and/or microbiological testing data.
• Excellent technical writing, analytical, and cross-functional communication skills.

Preferred: Experience with electronic Quality Management Systems (eQMS), such as TrackWise.