Manufacturing Assurance Specialist

Seeking a detail-oriented Investigation Specialist to support manufacturing operations by leading deviation investigations, identifying root causes, and ensuring effective corrective and preventive actions (CAPA) in a regulated (cGMP) environment.

Key Responsibilities:

• Investigate manufacturing deviations, environmental monitoring excursions, and calibration issues
• Perform root cause analysis and assess impact on product and production
• Collaborate with Manufacturing, Quality, Facilities, QC, and QA teams to resolve issues
• Generate clear, compliant investigation reports with corrective/preventive actions
• Support CAPA, change control, and documentation management (DCM) activities
• Review manufacturing, facility, and environmental monitoring records to support investigations
• Conduct facility and utility inspections and report potential risks
• Ensure compliance with regulatory and industry standards

Requirements:

• Hands-on experience in manufacturing, validation, or aseptic processing
• Strong technical writing, analytical, and problem-solving skills
• Experience with CAPA, deviation investigations, and root cause analysis
• Familiarity with cGMP, FDA regulations, and quality systems
• Proficiency in MS Office and systems such as SAP, LIMS, or DCM

Ability to work independently in a fast-paced, regulated environment