Capa Specialist Ii

Join our team as a Quality Investigator and play a critical role in ensuring that our products meet the highest standards of quality and safety. As a Quality Investigator, you will be responsible for independently leading complex investigations and ensuring that all investigations are written according to corporate and site requirements. You will also have the opportunity to promote a culture of continuous improvement by identifying problems, conducting root cause analysis, and implementing corrective and preventive actions. If you are passionate about quality and want to make a meaningful impact in a dynamic and collaborative environment, we encourage you to apply.

Responsibilities:

• Provides consistent and thoroughly written exception documents and timely resolution of investigations based on CAPA requirements.
• Coordinates the exception document process.
• Independently leads complex, high impact investigations.
• Drives exception and CAPA documents to ensure timely closure.
• Ensures all investigations are written according to corporate and site requirements.
• Ensures all applicable regulatory requirements are met for the implementation and maintenance of the Quality System.
• Ensures all Quality CAPA goals and metrics are met.
• Promotes culture of continuous improvement by identifying problems, conducting root cause analysis and confirming appropriate implementation of corrections, corrective and preventive actions.
• Maintains an effective liaison and cooperative relationship with other Quality areas and departments within the plant.

• Bachelor's degree, preferably in one of the following areas: Biology, Chemistry or Engineering.
• 6 years of experience in the pharmaceutical industry in Manufacturing, Quality or Engineering.
• Demonstrates ability to problem solve and utilize analytical skills.
• Knowledge of Quality/Compliance management, Regulations and Standards.