Quality Specialist, Regulatory

Quality Systems Specialist

The Quality Systems Specialist will manage internal ISO/Food Safety processes and schedule and support MRP Internal and External Audits under the direction of the Quality Assurance Manager. They are also responsible for administrative support to fulfill customer inquiries regarding compliance with applicable standards and regulations.

Essential Functions

• Lead representative for customer audits. Host audits as scheduled and follow up on reporting of any corrective action(s) required as a result of observations during the audits.
• Manages corrective action program. Issues corrective actions, monitor and track progress, and ensure timely response, verification, and evaluation of effectiveness by process owners.
• Manages internal audit program. Define internal audit schedule to ensure the QMS and FSMS are effectively implemented and are performing as intended.
• Maintain ISO9001:2015 and FSSSC22000 Management Systems.
• Report issues and escalate to management as needed.
• In conjunction with the maintenance manager, manages the pest control program
• Understand applicable industry requirements.

Qualifications

• Bachelor's Degree
• Or 3+ years' experience working in a similar role (Quality/Food Safety focused position)
• Experience using Microsoft Office software (Word, Excel, Outlook, PowerPoint, etc.)
• Excellent listening skills along with highly effective written and verbal communication skills
• Able to prioritize tasks
• Understanding of CFR 21, GFSI, ISO, DMF, and other food/pharmaceutical standards and expectations.

Food Safety Requirements

• Monitor and verify activities to ensure that all maintenance work in the facility meets food safety standards in addition to quality standards.
• Comply with all company food safety and quality assurance procedures and complete documentation correctly.
• Ensure all work product contact surfaces are restored to sanitary condition after any job completion.
• Report incidents, and product or process failures that could impact food safety of manufactured product to your direct reports and submit a safety/food safety incident report.