Location: Summit, NJ

Contract Duration: 6 months (possibility of extension for right candidate depending on performance)

Skills Required:

• Experience with deviation investigations using root cause analysis tools.
• Knowledge of the CAPA process and ability to identify and verify effectiveness.
• Technical writing skills and ability to collaborate effectively in cross-functional teams.
• Understanding and application of Global Regulatory and cGMP requirements.
• Knowledge of data trending and tracking, including use of statistical analysis software.
• Experience with electronic Quality systems such as eQRMs or Infinity.

Education and Experience:

• Bachelor's Degree in science or engineering, preferably in Biochemistry, life sciences, or related engineering discipline.
• Minimum 1 year of relevant work experience, preferably in a health authority regulated environment.
• Previous experience working in a biopharmaceutical manufacturing facility is preferred.

Job Responsibilities:

• Lead thorough investigations (Environmental Monitoring, deviations, etc.) using root cause analysis tools.
• Collaborate with functional teams to propose effective CAPAs, develop CAPA plans, and ensure CAPA effectiveness.
• Assess potential impact and risk associated with product or process changes and develop appropriate mitigation strategies.
• Provide technical support for manufacturing investigations, CAPAs, and change controls as needed.
• Support deviation investigation defense during audits and site inspections.
• Employ lean manufacturing/six sigma principles to continuously improve products, processes, and systems.