Responsible for compiling, reviewing, tracking and maintaining Annual Product Reviews (APRs). Responsible for performing APRs related to finished product, raw materials/components and customer complaints. Serves as back up for technical product complaint investigation process. Serves as back-up for incoming inspection disposition.
materials/components and customer complaints.
receipts which encompasses raw materials, filling components and
6. Any other duties as assigned.
BS degree in Natural Sciences, Engineering or related field.
4+ years of pharmaceutical/FDA regulated facility or related field required. Ability to work independently. Ability to communicate and work well with others. Familiar with component and label testing techniques. Knowledge of sampling plans (e.g. Mil standard) and GxP compliance requirements. Computer knowledge ; knowledge of ERPLx preferred but not a requirement. Six Sigma training and/or Minitab training preferred.