Deviation Investigations Specialist

Job Description

Job Description

Job Title: Deviation Investigations Specialist
Location: Davie, FL
Duration: 4 months-Temp to perm: Yes, based on performance and openings
100% Onsite - looking for local candidates
Shift Schedule: Monday – Friday, 8AM – 5PM. Should be flexible to work other shifts

Core Essential Skills:

• 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. A master’s degree in science or engineering is preferred but not required. We are primarily looking for candidates with the right combination of technical expertise, investigation experience, communication skills, and demonstrated ability to work effectively in a GMP manufacturing environment.
• Local candidates who can work onsite in Davie are strongly preferred.

Additional information that may help guide sourcing efforts:

• Strong background in pharmaceutical oral solid manufacturing, technical services, investigations, and related GMP environments.
• Experience leading deviation investigations, root cause analysis, CAPA development, and technical problem solving.
• Ability to analyze manufacturing, machine and laboratory data, identify trends, and make scientifically sound recommendations.
• Excellent written and verbal communication skills, as the role requires authoring clear and concise technical reports and interacting with cross-functional teams.
• Strong understanding of GMP requirements, data integrity principles, and regulatory expectations.
• Experience working in a fast-paced manufacturing environment and supporting commercial operations.
• Exposure or active work in OPEX, potentially green belt or black belt certification.
• Candidates who would stand out are those with:
• Direct pharmaceutical manufacturing experience.
• Experience writing and leading complex investigations.
• Strong analytical and critical thinking skills.
• Exposure to process validation, technical transfers, continuous improvement, automation, or digital tools.
• Ability to effectively collaborate across Manufacturing, Quality, Engineering, and Regulatory functions.

POSITION SUMMARY
This position is responsible for leading and performing cGMP investigations supporting Oral Solid Dose (OSD) manufacturing, including complex manufacturing processes and equipment. The Investigator I authors and coordinates high-quality investigations for events occurring in Production, Engineering, Quality Control (QC) Laboratory, and related support areas, ensuring timely root cause identification, appropriate product impact assessments, and implementation of effective Corrective and Preventive Actions (CAPAs) to maintain compliant supply.
The role applies scientific and technical judgment to evaluate manufacturing and laboratory data, interviews and observation, equipment/utilities performance, and process parameters to support robust root cause analysis and sustainable remediation for OSD unit operations (e.g., blending, granulation, compression, coating, encapsulation, etc.) and associated systems.

ESSENTIAL AREAS OF RESPONSIBILITY

• 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).

POSITION REQUIREMENTS
Education/Certification/Experience:

• 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

Skills/Knowledge/Abilities:

• 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.

#sczr2