Investigation Specialist

Investigations Specialist with experience in regulated industries and strong knowledge of complaints and deviation processes. The specialist will be responsible for performing thorough, detailed, and timely investigations and for the generation of high-quality, timely investigation reports. Must be available to travel to the United States immediately.

Responsibilities:

• Understand the investigation process as it applies to manufacturing issues and complaints.
  
• Understand the processes and systems involved in the manufacture of biopharmaceutical products.
  
• Investigate process deviations and atypical/out-of-specification results and identify root cause.
  
• Conduct investigations with strict adherence to the applicable quality and compliance standards.
  
• Develop and document corrective and preventive actions (CAPA) and verify their effectiveness.
  
• Coordinate with Subject Matter Experts (SMEs) across functions to gather and verify the information required for the investigation.
  
• Exercise judgment in developing practices, techniques, and evaluation criteria for obtaining results.
  

Requirements

·         Bachelor's degree in Science and five (5) years of experience in manufacturing investigations.

·         Background in biology or chemistry and investigations.

·         Bilingual (Spanish / English).

·         Computer literacy.

·         Available to travel to the United States immediately.