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MS&T Specialist Deviations Investigator

ICONMA, LLC

  • Davie, FL
  • 30+ days ago
  • $35.06 Per Hour
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Skills

  • Analysis Skillsunmatched
  • Artificial Intelligence (AI)unmatched
  • Biotech and Pharmaceuticalunmatched
  • Communication Skillsunmatched
  • Continuous Improvementunmatched
  • Corrective Actionunmatched
  • Corrective and Preventative Action (CAPA) Systemsunmatched
  • Cross-Functionalunmatched
  • Current Good Manufacturing Practice (cGMP)unmatched
  • Data Analysisunmatched
  • Documentationunmatched
  • Drug Manufacturingunmatched
  • Environmental Monitoringunmatched
  • Equipment Maintenance/Repairunmatched
  • Event Managementunmatched
  • Health Planunmatched
  • Identify Issuesunmatched
  • Laboratoryunmatched
  • Laboratory Equipmentunmatched
  • Laboratory Information Management System (LIMS)unmatched
  • Manufacturingunmatched
  • Manufacturing Analysisunmatched
  • Manufacturing Operationsunmatched
  • Manufacturing Systemsunmatched
  • Manufacturing/Industrial Processesunmatched
  • Negotiation Skillsunmatched
  • Problem Solving Skillsunmatched
  • Procedure Implementationunmatched
  • Quality Assuranceunmatched
  • Quality Controlunmatched
  • Reporting Dashboardsunmatched
  • Riskunmatched
  • Root Cause Analysisunmatched
  • Safety/Work Safetyunmatched
  • Structured Analysisunmatched
  • Supervisory Control and Data Acquisition (SCADA)unmatched
  • Technical Presentationunmatched
  • Technical Writingunmatched
  • Testingunmatched
  • Time Managementunmatched
  • Writing Skillsunmatched

Description

Our Client, a Pharmaceuticals company, is looking for a MS&T Specialist – Deviations Investigator for their Davie, FL location.
 
Responsibilities:
  • 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 and/or co-author cGMP investigations for OSD manufacturing and complex operations (deviations/nonconformances/atypical events), ensuring clear problem statements, accurate timelines, and timely closure in the quality system.
  • Coordinate event triage and immediate actions, including containment and escalation, and support batch disposition decisions with Operations, Engineering, QC, and QA.
  • Collect, organize, and analyze manufacturing, engineering, and laboratory evidence (e.g., batch records, equipment/maintenance logs, MES/SCADA/historian data, calibrations, environmental monitoring, and test results) to establish event sequence and contributing factors.
  • Facilitate cross-functional root cause analysis using structured tools (e.g., 5-Why, fishbone, fault tree as applicable) and document technically sound, compliant conclusions and product impact assessments.
  • Define, document, and track CAPAs (correction/corrective/preventive actions) with appropriate due dates and effectiveness checks; support on-the-floor verification and implementation to prevent recurrence.
  • Prepare clear, complete investigation/CAPA records; support trending and continuous improvement; and participate in audit/inspection readiness by providing evidence packages and responses (while maintaining required training and safe work practices).
 
Requirements:
  • Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.
  • Master’s or Ph.D. degree in a scientific or engineering discipline with relevant experience supporting investigations within pharmaceutical manufacturing, engineering, and/or QC laboratories; oral solid dosage (OSD) experience preferred.
  • Experience using electronic quality systems and manufacturing/laboratory data systems (e.g., deviation/CAPA systems, MES, LIMS, historian/trending tools, AI tools) to support investigations, trending, and effectiveness monitoring preferred
  • OSD manufacturing and complex process/equipment knowledge sufficient to investigate events across Production, Engineering, and QC (e.g., blending, granulation, compression, coating, encapsulation, and supporting utilities).
  • Strong Technical writing and documentation skills (deviations/nonconformances, OOS/OOT as applicable, product impact assessments, CAPA, and effectiveness checks) using Good Documentation Practices (GDP).
  • Knowledge of cGMP, pharmaceutical quality systems, and data integrity expectations applicable to investigations, CAPA, and inspection readiness.
  • Analytical and problem-solving capability using structured root cause analysis tools (e.g., 5-Why, fishbone, fault tree) to separate symptoms from true root causes.
  • Ability to interpret and trend manufacturing/equipment/lab data using available systems and tools (e.g., 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 clearly presenting complex technical information.
  • Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
  • Seeks out all resources when selecting methods and techniques for obtaining results.
  • Acts independently and proactively to recommend and administer methods and procedures for problem resolution.
  • Able to identify solutions to general problems through collaboration and creativity.
  • This role will focus heavily on internal troubleshooting within Client and require frequent cross-functional collaboration. The individual should be confident in navigating conversations across teams, with strong negotiation skills and the ability to communicate effectively and proactively.
  • Minimum Master’s degree
 
Why Should You Apply?  
ICONMA is an Equal Opportunity Employer. All qualified applicants will receive considerationfor employment without regard to any status protected by applicable law.
 
 

Numbers & Facts

LocationDavie, FL
Salary$35.06 Per Hour

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