0058V6397 Deviation Investigator/Senior Quality Specialist Consultant

Two River Consulting Partners • Columbus, OH

8d • Onsite

About The Position

This role involves investigating deviations, identifying root causes, and implementing corrective and preventive actions (CAPA). The Deviation Investigator will be responsible for initiating quality records, conducting thorough investigations, assessing product quality impact, and collaborating with various departments and stakeholders. Responsibilities also include resolving comments, retrieving documents, and conducting operator interviews.

Requirements

• Timely initiation and completion of quality records.
• Thoroughness and accuracy in deviation investigations.
• Meeting the minimum requirement of closing deviations per week.
• Effectiveness in identifying and implementing CAPA measures.
• Possible availability and responsiveness during weekends.
• Efficient resolution of internal and client comments.
• Competency in retrieving supporting documents and conducting interviews.

Responsibilities

• Initiate quality records promptly and accurately for identified deviations, ensuring alignment with both industry and Client expectations.
• Conduct thorough investigations for identified deviations, employing root cause analysis methodologies.
• Assess the impact on product quality with input from various departments.
• Identify and recommend Corrective and Preventive Actions (CAPA) based on investigation findings.
• Collaborate with stakeholders to ensure the effective implementation of CAPA measures.
• Timely resolution of internal and client comments related to investigations.
• Collaborate with relevant parties to address and close out comments effectively.
• Retrieve necessary supporting documents to substantiate investigation findings.
• Conduct interviews with manufacturing operators to gather relevant information.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed