The Specialist II in Quality Assurance Labeling Systems, Change Control, is responsible for monitoring systems in support of FDA regulations and ISO standards, reviewing data, participating in investigations, and conducting routine process analyses. The impact of errors in the QS II position can be viewed as medium to high, depending on the discrete task being worked on. Potential errors could result in unacceptable materials being allowed in the manufacturing process and citations for regulatory noncompliance.
• Core support for Labeling Change Control and as the chief administrator of the inventoried Labeling Inspection process; these activities are in support of FDA regulations and ISO standards.
• Resource for Labeling Change Control participants on issues related to change control and manufacturing on issues pertaining to product quality.
• Significant amount of time will be spent directly interacting with Labeling change order reviewers and manufacturing staff.
• Works on projects of diverse scope, which includes the analysis of data and processes.
• Responsible for ensuring on-going compliance to applicable quality and EHS regulations and standards (e.g., ISO, US FDA, MDD, IVDD, EU-PSHA, OSHA, etc.).