Deviation Investigations Specialist

We are looking for Deviation Investigations Specialist for our client in

Davie, FL Job Title:

Deviation Investigations Specialist Job Location:

Davie, FL Job Type:

Contract Job Overview:

Responsibilities:

Lead and co-author cGMP investigations for OSD manufacturing, including deviations, nonconformances, and atypical events. Ensure clear problem statements, accurate timelines, and timely closure of investigations within the quality system. Coordinate event triage, containment actions, and escalation while supporting batch disposition decisions. Collect, organize, and analyze data from manufacturing, engineering, and laboratory sources such as batch records, equipment logs, MES, SCADA, and test results. Establish event sequences and identify contributing factors through detailed data analysis. Facilitate root cause analysis using structured methodologies such as 5-Why, fishbone, and fault tree analysis. Document technically sound conclusions and perform product impact assessments. Define, implement, and track CAPAs, including corrective and preventive actions with effectiveness checks. Support on-the-floor verification and ensure implementation of corrective actions to prevent recurrence. Prepare and maintain complete investigation and CAPA documentation in compliance with regulatory standards. Support trending, continuous improvement initiatives, and audit/inspection readiness activities. Provide documentation, evidence packages, and responses during audits and inspections.

Required Skills And Experience:

Master s or Ph.D. degree or equivalent combination of education, training, and experience. Strong knowledge of OSD manufacturing processes such as blending, granulation, compression, coating, and encapsulation. Experience with cGMP regulations, pharmaceutical quality systems, and data integrity requirements. Proficiency in root cause analysis tools such as 5-Why, fishbone, and fault tree analysis. Experience using electronic quality and data systems such as eQMS, MES, LIMS, and historian tools. Strong analytical skills with the ability to interpret and trend manufacturing, equipment, and laboratory data. Ability to manage multiple investigations and work cross-functionally with stakeholders. Strong written and verbal communication skills to present complex technical information clearly. Proficiency in Microsoft Office tools, especially Excel for data analysis and reporting.

Preferred Qualifications:

Experience with AI tools and advanced data analysis platforms for investigation and trending. Prior experience supporting regulatory audits and inspections. Strong understanding of CAPA management and effectiveness monitoring. Experience working in pharmaceutical or life sciences manufacturing environments.

Problem Solving And Competencies:

Ability to independently handle moderate to complex problems involving multiple variables and data sources. Strong critical thinking and decision-making skills to identify root causes and implement effective solutions. Proactive approach to recommending and implementing process improvements. Collaborative mindset to solve problems through teamwork and cross-functional engagement.