Summary

The Investigator is responsible to lead, conduct and document investigations relating to non-conformances and/or complaints within the Sharp Clinical sites.

The Investigator will utilize root cause analysis tools, critical thinking and interviewing techniques to determine the root and contributing causal factors of non-conformances/complaints. 

Investigator will offer recommendations to correct and/or prevent recurrence through CAPA design from the root cause conclusion of the investigation. The Investigator will lead, as necessary, the implementation of associated corrective and preventative actions through collaboration, teamwork and influence.  The position will work closely and in collaboration with internal and occasionally external stakeholders.

Essential Duties and Responsibilities

• Identifies issues and can independently assess the need for non-conformance and formulate recommended containment actions in conjunction with operational leadership.

• Manage investigations in an effort for timely completion, updating procedures and assistance with training support for correction of errors as required

• Support site departments with investigations, complaints, process improvement and training for NCRS and complaints as well as the subsequent Corrective and Preventive Actions (CAPAs).

• Conduct investigations that identify robust root cause by effectively applying root cause analysis tools across a variety of non-conformance and/or complaint types.

• Observe processes on shop floor, warehouse, and central support functions (Quality Control, Receiving, Distribution) to ensure investigations are objective and detailed.

•  Author investigation reports in QualityOne (QMS) utilizing strong organizational and technical writing skills with demonstrated attention to detail.

• Support department leadership with training improvements to prevent reoccurring process issues.

• Work with Quality Systems group to develop process and best practices for managing the GMP training program. Proactively identify and facilitate resolution of potential risks.

• Collaborate with subject-matter experts (SME) to ensure specialized subjects are appropriately addressed. Generate innovative ideas for content and workflow solutions with SME. Coordinate internal meetings/training with Supervisors and impacted areas.

• Must be flexible to meet the needs to the organization when required (competing due dates and customer prioritization)

• Analyze information required for the development or update of policy, procedure and form documentation. Willingness to take on new challenges and build on current skills.

• Assist in other activities (as needed) for Quality management

• Achieve expected key performance measures.

• Other duties as assigned.