Job Description
What We're Looking For We are seeking a highly skilled and detail-oriented Investigation Specialist with expertise in Analytical Chemistry to join our team. This role is responsible for leading and supporting investigations related to laboratory deviations, out-of-specification (OOS) results, and other quality-related issues. The ideal candidate will possess strong analytical capabilities, a thorough understanding of laboratory operations, and the ability to interpret complex scientific data to drive effective root cause analysis and corrective actions. What You Will Do Lead, conduct, and document investigations into laboratory deviations, non-conformances, OOS/OOT (Out-of-Trend) results, and quality events. Perform detailed root cause analysis using analytical data, laboratory records, and supporting documentation. Analyze and interpret complex analytical chemistry data to identify trends, anomalies, and potential risks. Develop, recommend, and track corrective and preventive actions (CAPAs) to ensure timely and effective resolution. Prepare clear, concise, and compliant investigation reports in accordance with internal procedures and regulatory requirements. Collaborate cross-functionally with Quality Assurance, Production, R&D, and Regulatory Affairs to support investigations and implement solutions. Ensure investigations are completed within established timelines and meet compliance standards. Support internal and external audits by providing documentation and subject matter expertise as needed. Identify recurring issues or trends and contribute to continuous improvement initiatives. Maintain a strong understanding of current regulatory guidelines and industry best practices related to analytical chemistry and quality systems. Who You Are Bachelor's degree in Chemistry, Analytical Chemistr