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MS&T Specialist Deviations Investigator

ICONMA, LLC

Davie, FL

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JOB DETAILS
SALARY
$35.06 Per Hour
SKILLS
Analysis Skills, Artificial Intelligence (AI), Biotech and Pharmaceutical, Communication Skills, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Analysis, Documentation, Drug Manufacturing, Environmental Monitoring, Equipment Maintenance/Repair, Event Management, Health Plan, Identify Issues, Laboratory, Laboratory Equipment, Laboratory Information Management System (LIMS), Manufacturing, Manufacturing Analysis, Manufacturing Operations, Manufacturing Systems, Manufacturing/Industrial Processes, Negotiation Skills, Problem Solving Skills, Procedure Implementation, Quality Assurance, Quality Control, Reporting Dashboards, Risk, Root Cause Analysis, Safety/Work Safety, Structured Analysis, Supervisory Control and Data Acquisition (SCADA), Technical Presentation, Technical Writing, Testing, Time Management, Writing Skills
LOCATION
Davie, FL
POSTED
30+ days ago
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.
 
 

About the Company

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ICONMA, LLC

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