1515 Memorial Drive

Manitowoc, WI 54220

(920) 684-5575

Fax: (920) 684-1915

Mon - Fri: 8:00 - 4:30

Quality Assurance and Compliance Manager

Posted: 02/26/2023

Quality Assurance and Compliance Manager
Work with Production,Quality Control and Operations to ensure all products manufactured at Northern Labs meet established specifications in both product making and filling areas.  This is to be accomplished through process and quality compliance and audits to ISO 9001 and FDA-cGMP standards and any other applicable regulatory requirements.  The purpose is to maintain regulatory compliance through validation, corrective action and other process improvement activities. 
Create and perform all validation activities as needed to support existing/new customers or internal process improvements. Communicate with customers (as necessary) regarding validation activities, quality issues, and obtaining approvals on final protocols. Process and manage CPA’s (corrective/preventive action) and deviations to support continuous improvement activities.  Include root cause analysis as needed. Conduct and manage Annual Product Reviews (APR’s) as needed to support compliance with FDA and Health Canada regulations.