Job Title: Deviation Investigations Specialist
Location: 100% Onsite - looking for local candidates in Davie
Salary Range: $35.00/hr
Introduction
This position is responsible for leading and performing cGMP investigations supporting Oral Solid Dose (OSD) manufacturing, including complex manufacturing processes and equipment. The role involves authoring and coordinating 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.
Required Skills & Qualifications
- Minimum Master’s degree in Science or Engineering 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.
- Excellent written and verbal communication skills.
- Prior work experience at client or in client's industry.
Preferred Skills & Qualifications
- Direct pharmaceutical manufacturing experience.
- Experience writing and leading complex investigations.
- Exposure to process validation, technical transfers, continuous improvement, automation, or digital tools.
Day-to-Day Responsibilities
- Lead and/or co-author cGMP investigations for OSD manufacturing and complex operations, ensuring clear problem statements and timely closure in the quality system.
- Coordinate event triage and immediate actions, including containment and escalation, and support batch disposition decisions.
- Collect, organize, and analyze manufacturing, engineering, and laboratory evidence to establish event sequence and contributing factors.
- Facilitate cross-functional root cause analysis using structured tools and document compliant conclusions and product impact assessments.
- Define, document, and track CAPAs with appropriate due dates and effectiveness checks.
Company Benefits & Culture
- Exposure to a fast-paced manufacturing environment.
- Opportunities for continuous improvement and professional growth.
- Collaborative work environment with cross-functional teams.
For immediate consideration please click APPLY to begin the screening process with Alex.