Investigator

Investigator

One of our large pharmaceutical clients in Spring House, PA is seeking an Investigator to join their growing team supporting the Cell Therapy Development organization within R&D. This person will be responsible for driving nonconformance investigations end-to-end, including root cause analysis, risk analysis, creating and owning corrective action plans, and updating procedures accordingly. This position requires analytical thinking, organizational leadership, and strong written and verbal communication skills.

Primary responsibilities include:

• Independently run investigations (non-conformance, deviations, invalid assays)
• Author and execute corrective and preventative action record and execute CAPAs
• Track deviations and provide reports to management on trending as it relates to assigned investigations

Additional responsibilities may include:

• Identify gaps in processes or systems based on current and future regulatory requirements and communicate necessary changes to leadership and appropriate stakeholders
• Risk assessments
• Manage change through change control process and support internal and external audits
• Keep track of regulatory requirements and changes and perform Gap Assessments as needed
• Process improvement