NOI Investigations Specialist

Description:

The NOI Investigations Specialist plays a critical role in ensuring product quality, compliance, and patient safety by conducting comprehensive investigations into quality events that may impact the manufacturing, release, distribution, or shelf life of commercial products. Leveraging strong analytical, technical, and interviewing skills, this individual independently and collaboratively gathers and evaluates data, identifies root causes, assesses product impact, and develops effective corrective and preventive actions (CAPAs) to prevent recurrence. The role requires sound judgment in determining product disposition, with decisions potentially affecting regulatory commitments, business performance, customer satisfaction, and product availability. The specialist is responsible for clearly documenting and communicating investigative findings, supported by scientific rationale and factual evidence, in a manner that withstands scrutiny from regulatory agencies, custom...