Quality Analyst Systems & Compliance - Days

Description Overview

The Quality Analyst Systems & Compliance (Internal Compliance Auditor) position is responsible for conducting internal audits of Quality, Food Safety, Operations and Maintenance related systems at the Perrigo Wisconsin factory.  Audits include, but are not limited to ISO22000, ISO22002, FSSC, 21CFR106, 21CFR107, 21CFR117, customer specific requirements (Halal/Kosher/Non-GMO, etc), regulatory requirements, as well as Perrigo Global Procedures.  This person is responsible for the administration of the Corrective and Preventive Action system. In addition, they will manage the facilities mock recall program and traceability program. 

Scope of the Role

• Plans audits, making effective use of resources, represent audit teams with respect to communication with process owners, organizes and directs audit team, and provides direction and guidance team. 
• Develop and maintain the required training material for the CAPA system and mock recall program. Train and coach on the required elements to ensure that team members have the needed knowledge of systems and procedures. 
• Review corrective and preventive action incidents and assist in determination of action owner, course of action, and verify the effectiveness of actions completed. 
• Maintain corrective and preventive action records in Trackwise program. Work with action owners to close tasks. 
• Identifies and communicates trends in non-conformances to process owners and Quality team members. 
• Coordinate with internal resources as well as external auditors to schedule and facilitate audits. 
• Summarize and present audit findings to process owners and management. 
• Represents factory during external audits of management systems. 
• Coordinate mock recall/traceability program. Train key personnel on team members on performing mock recalls and traceability tasks. 
• Understand the food safety and quality aspects of the position as indicated by OJTs and SOPs. 
• Follow current Good Manufacturing Practices and all related procedures and programs. 
• Throughout all responsibilities, maintain a focus on continuous improvement. 
• Performs other duties as assigned.

Experience Required

• Bachelor’s Degree in Food Science, Chemistry, Microbiology, or related field or equivalent work experience in a related field. 
• Experience working with a regulated company with audit background and strong understanding of interpreting regulatory requirements.
• Minimum of 3-5 years of related Quality experience
• Experience in regulated food manufacturing environment with exposure to 21 CFR 117, lean manufacturing, FSSC22000/SQF regulations and preferred experience with 21 CFR 106/107 and 21 CFR 113

Additional Skills:

• Advanced communication skills, including technical writing and history of cross functional collaboration.     
• Capable of performing public speaking roles, including group training. 
• Developed coaching skills. 
• Ability to prioritize workload and maintain flexibility to adapt to changing business needs. 
• Competence in advanced decision-making processes.
• Focused attention to detail and commitment to Quality 
• Knowledge or experience in Microsoft suite programs. SAP experience is preferred.