Key Responsibilities:

The RCA Specialist will be responsible to:

• Lead the investigation/root cause analysis, corrective/preventive action (CAPA) plan development for assigned cases
• Support implementation of assigned plan components and tracking of actions to completion as necessary
• Ensure documentation of root cause analysis and CAPA plan are accurate, complete and inspection ready

Root Cause Analysis/Due Diligence

This individual will also be required to apply a root cause methodology and/or due diligence approach to the case. This individual may either lead QE cases from start to finish or be brought in conduct just the RCA portion of the investigation for systemic issues, process related issue or business critical cases.

Training

This individual will also be required to train new Investigation Case Leads in the Root Cause Analysis Methodology and provide mentoring to new Investigation Case Leads while they obtain RCA Certification.

The RCA Specialist will also be a subject matter expert in the Human Performance (PHP) methodology and will be a resource to case leads to implement PHP in the investigation process and help teams error proof the process in question.

CAPA Plan Development and Management

Based on identified root causes, the individual will guide the SQE team in identifying appropriate corrective and preventive actions and conducting effectiveness checks on implemented actions to ensure they are working as expected.

Leverage process improvement best practice techniques (i.e., Six Sigma, Lean, etc.); analyze and optimize current business processes and develop and implement new business processes.

This individual will hold accountability for ongoing monitoring of CAPA completion and tracking of effectiveness for implemented mitigation actions to ensure they are working as expected—for quality events, inspections and audits

• Ensure implementation of QE / audit / inspection CAPAs and remediation plans
• Track effectiveness checks and report on trends.

• Minimum of 5 years of pharmaceutical experience with solid experience in clinical operations aspects, GCP Quality, GxP Quality, and/or regulatory in a clinical research or pharma environment required
• Regulatory inspection experience
• Process and system management experience
• Detailed knowledge of clinical trial processes and relationships required
• Knowledge of GCP requirements and applicable SOPs and regulations
• Project management, administrative, and technical capabilities are required, as well as effective verbal and written communication skills
• Strong background in continuous improvement methodology (i.e., Lean Six Sigma) preferred
• Previous Experience in conducting Root Cause Analysis, Error Proofing/Mistake Proofing and familiar with Human Performance (PHP) and help analyze trends in data to identify potential investigations to address systemic process issues or program/protocol level issues.
• This role will involve working with Vendor Quality and Clinical Quality colleagues.
• Work with Vendor Quality and Clinical Quality groups to assist in developing investigation strategies related to vendor issues and program level quality issues.
• Experience in leading process improvement efforts from inception to execution

Education: