Deviation Investigations Specialist

Job Title: Deviation Investigations Specialist Davie, FL (100% Onsite - looking for local candidates) Until end of the year with possible extension Temp to perm: Yes based on performance and openings Core Essential Skills: Heavy focus on internal troubleshooting and cross-functional collaboration ; strong communication, negotiation, and proactive stakeholder management skills required. Master’s degree minimum ; Science/Engineering preferred. Strong emphasis on technical expertise, investigation experience, communication, and GMP manufacturing experience . Local candidates able to work onsite in Davie, FL are strongly preferred.

POSITION SUMMARY

Leads and conducts cGMP investigations for OSD manufacturing, covering Production, Engineering, QC, equipment, and complex manufacturing processes. Performs root cause analysis, product impact assessments, and CAPA implementation using manufacturing/lab data, interviews, observations, equipment/utilities performance, and process parameters across operations such as blending, granulation, compression, coating, and encapsulation , ensuring compliant supply and sustainable remediation.

ESSENTIAL AREAS OF RESPONSIBILITY

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments. Lead/co-author cGMP investigations for OSD deviations, nonconformances, and atypical events. Coordinate event triage, containment, escalation, and batch disposition with Operations, Engineering, QC, and QA. Analyze batch records, equipment/MES/SCADA data, maintenance logs, calibrations, and lab results to identify contributing factors. Facilitate root cause analysis using 5-Why, Fishbone, Fault Tree, and document product impact. Define and track CAPAs, due dates, and effectiveness checks to prevent recurrence. Maintain investigation/CAPA records, support trending, continuous improvement, and audit/inspection readiness .

POSITION REQUIREMENTS

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered. Education/Certification/Experience: Master’s/Ph.D. in Science or Engineering with relevant pharmaceutical manufacturing, Engineering, or QC investigation experience; OSD preferred . Experience with eQMS, MES, LIMS, data/trending, and AI tools for investigations, trending, and CAPA effectiveness monitoring. Skills/Knowledge/Abilities: OSD manufacturing & equipment knowledge across blending, granulation, compression, coating, encapsulation, and utilities. Strong technical writing/documentation for deviations, OOS/OOT, impact assessments, CAPA, and effectiveness checks. Strong knowledge of cGMP, quality systems, data integrity, and inspection readiness . Expertise in root cause analysis using 5-Why, Fishbone, Fault Tree, etc. Ability to analyze/trend data using eQMS, MES, LIMS, Excel, and dashboards . Strong cross-functional communication, investigation management, and technical presentation skills. #J-18808-Ljbffr Unicon Pharma Inc