CAPA Process Analyst II

Description:

• Years Experience: 4 Years

The CAPA Process Analyst II:

• Conducts investigations of nonconformances/quality events and progresses the associated quality records through QMS platform in accordance with established procedures.
• Collaborates with cross-functional teams to support investigations and ensure corrective actions are appropriate.
• Ensures that corrective and preventive actions are appropriate accurately and completely documented implemented on time and meet the required procedural and regulatory standards.
• Interacts cross-functionally ensuring that all communications interpersonal interactions and business behaviors are consistent with the Code of Conduct.

Main Responsibilities:

• Leads the investigation of complex and highly technical quality issues and ensures the timely completion of CAPA system activities initiated to address nonconformances potential nonconformances deviations and/or complaints.
• Executes investigations and CAPAs in accordance with established procedures ensuring consistency with quality system requirements.
• Serves as a subject matter expert in conducting investigations and performing root cause analysis to ensure that root and potential causes are appropriately identified and mitigated/eliminated.
• Collaborates with laboratory operations and technical staff to conduct investigations and ensure corrective actions are appropriate and effectively implemented.
• Maintains CAPA system records to ensure audit-readiness for internal and external quality system audits.
• Ensure CAPA documentation is accurate well-structured and compliant with procedural requirements and regulatory guidelines.
• Supports the initiation and implementation of improvement activities associated with identified trends.
• Escalates potential compliance risks quality concerns or procedural gaps to the Quality Manager to ensure timely evaluation and resolution.
• Demonstrates effective written and verbal communication skills.
• Prioritizes workload in relation to business needs.
• Supports the attainment of Toxicology Laboratories goals and objectives.
• Performs other duties as assigned by the Quality Manager.

Required Qualifications:

• Bachelors degree in Life Sciences
• Experience with Corrective and Preventative Action process in regulated environments pharmaceuticals medical devices or laboratories
• Excellent communication and technical writing skills
• Experienced in working with QMS platforms

Preferred Qualifications:

• ASQ CQA
• Project management experience
• Knowledge of College of American Pathologists (CAP) regulations NLCP regulations or similar regulations (i.e. FDA).
• Experienced in navigating Agile