MS&T - Deviations Investigator. at Aequor Davie, FL

MS&T Specialist – Deviations Investigator Location: Davie, FL | Shift: Monday – Friday 8:00am – 5:00pm | Duration: 6months | Temp to Perm: Possible based on performance and openings Position Summary This role leads and performs cGMP investigations supporting Oral Solid Dose (OSD) manufacturing, including complex processes and equipment. The investigator authors and coordinates high‑quality investigations for events occurring in production, engineering, quality control laboratories, and related support areas, ensuring timely root‑cause identification, product impact assessments, and implementation of corrective and preventive actions (CAPAs) to maintain a compliant supply. Essential Areas of Responsibility Lead or co‑author cGMP investigations for OSD manufacturing and complex operations, ensuring clear problem statements, accurate timelines, and timely closure. Coordinate event triage and immediate actions, including containment, escalation, and batch disposition decisions with operations, engineering, QC, and QA. Collect, organize, and analyze manufacturing, engineering, and laboratory evidence (batch records, equipment logs, MES/SCADA data, calibrations, environmental monitoring, test results) to establish event sequence and contributing factors. Facilitate cross‑functional root‑cause analysis using structured tools (5‑Why, fishbone, fault tree) and document technically sound, compliant conclusions and product impact assessments. Define, document, and track CAPAs with due dates and effectiveness checks; support on‑floor verification and implementation to prevent recurrence. Prepare clear investigation/CAPA records, support trending and continuous improvement, and participate in audit/inspection readiness by providing evidence packages and responses. Maintain required training and safe work practices while supporting trending, continuous improvement, and audit/inspection activities. Position Requirements Master’s or Ph.D. degree in a scientific or engineering discipline; relevant experience supporting investigations within pharmaceutical manufacturing, engineering, or QC laboratories. OSD experience preferred. Experience using electronic quality systems and manufacturing/laboratory data systems (deviation/CAPA systems, MES, LIMS, historian/trending tools, AI tools) to support investigations, trending, and effectiveness monitoring. Knowledge of OSD manufacturing and complex process/equipment sufficient to investigate events across production, engineering, and QC. Strong technical writing and documentation skills using Good Documentation Practices (GDP) for deviations, nonconformances, product impact assessments, CAPAs, and effectiveness checks. Knowledge of cGMP, pharmaceutical quality systems, and data integrity expectations applicable to investigations, CAPAs, and inspection readiness. Analytical and problem‑solving capabilities using structured root‑cause analysis tools (5‑Why, fishbone, fault tree). Ability to interpret and trend manufacturing/equipment/lab data using systems and tools (eQMS, MES, LIMS, historian/trending tools, Excel dashboards) to support risk‑based decisions. Effective cross‑functional facilitation and communication skills, including managing multiple investigations, aligning stakeholders, and presenting complex technical information clearly. Proactive, independent problem solving with a moderate to complex scope, using resources and methods to obtain results and recommend solutions through collaboration and creativity. #J-18808-Ljbffr Neier Inc.