Quality Assurance Manager

Quality Assurance ManagerATTRACTIVE SKILLS / EXPERIENCES:Bachelor's Degree in Chemistry, Biology, Engineering or related field (required)Experience (3+ years) in a leading/managing a Quality Department/GroupDemonstrated knowledge of ISO standards (9001; 14001; 15378) along with cGMPExperience and knowledge with MS Office applications (especially MS Excel)Experience and knowledge with SAP and electronic QMS systemsDemonstrated communication skills (written / oral) including the ability to read/speak EnglishAbility and willingness to work in office and in a production floor setting with moderate noiseAbility and willingness to work in fast-paced, matrix structured organizationWilling to work traditional business hours (8am to 5pm) during weekdays (M-F) with the flexibility to accommodate supporting the 24/7 shift scheduleSUMMARY / RESPONSIBILITIES: Assist in developing department budget and investment plan(s) according to strategic goalsCultivate employee talent through training and coaching measures, while also conducting employee performance reviewsSupport the development and updating of Quality Assurance programs, policies, processes, procedures and controlsReview, analyze and report on quality discrepancies related to SCHOTT products, while developing disposition and corrective actions for product discrepanciesManage the review of batch records and avoid impacting shipment datesManage Department Training Coordinator activities and projectsManage document control activities to include, releasing, archiving, tracking and reporting of the document review process for controlled documentsLead and support the implementation of Systems and Compliance Improvements including site compliance, along with data integrity requirementsMeasure and analyze Quality System trendsOversee the internal audit function to ensure ongoing compliance to the Quality Management System (QMS)Maintain the Archive Room and document retention requirementsWrite and revise Standard Operating Procedures (SOPs) and provide training, as requiredManage the CAPA and Change-Control process to include, issuing, reviewing and approving stepsSupport all customer or registrar quality related audits and/or evaluationsUtilize quality tools, including Compliant-PRO, etc., for information, tracking and reporting purposes, as required by the Pharm Business UnitManage assigned CAPA(s) by performing root cause investigations, while defining resolution actions; implement preventive and corrective actions in a timely manner as a result of customer complaints or customer audit findingsHelp promote and implement safety/EHS directives and maintain a clean and safe workspaceAssure compliance with ISO certifications and cGMP, along with adherence to Company policies and procedures and Code of Conduct/safety guidelines