Job Summary

The Operations-Compliance Specialist II is responsible for handling product quality investigations. The role works cross-functionally and independently to collect information used to identify the root cause and mitigate reoccurrence of aberrant events and circumstances impacting the products. Initiate appropriate corrective action preventative action (CAPA) to prevent deviation.

Essential Functions

• Lead investigations for manufacturing and bring them to a resolution with minimal direct supervision. Assess aberrant events impacting product quality that could prevent product release. Performs interviews and schedule follow-up meetings in response to investigations.
• Supports the business through schedule/timeline adherence of investigations closures to allow for timely new product launches, and batch releases.
• Perform gap assessments and root cause analysis evaluations to determine the exact cause of incident. Monitor CAPA effectiveness and track the control.
• Identify and resolve objectionable cGMP issues which may impact product quality and escalate the issues to supervisor in a timely manner.
• Utilize technical writing skills to a broad audience, translate moderate to complex scientific events into a brief and cohesive report as a clear and concise document, to withstand regulatory requirement.
• Participate in the management meetings to update leadership on current status of quality events. Prepares weekly/monthly status reports.

Additional Responsibilities

• Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements.