Investigation and Deviation Specialist

Temp-to-perm: 6-month contract with potential for permanent placement based on performance and openings. 100% onsite; local candidates in Davie strongly preferred.

Schedule

Monday–Friday, 8:00 AM–5:00 PM. Flexibility to work other shifts as needed.

About the Role

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.

Responsibilities

• 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

• Bachelor’s or Master’s 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.
• 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, including 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.

Skills

• 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 moderate to complex scope, analyzing situations or data with in-depth knowledge of known and unknown factors.
• Acts independently and proactively to recommend and administer methods and procedures for problem resolution.

Preferred Qualifications

• 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.