Quality Assurance Manager

Quality Assurance Manager

ATTRACTIVE SKILLS / EXPERIENCES:

• Bachelor's Degree in Chemistry, Biology, Engineering or related field (required)
• Experience (3+ years) in a leading/managing a Quality Department/Group
• Demonstrated knowledge of ISO standards (9001; 14001; 15378) along with cGMP
• Experience and knowledge with MS Office applications (especially MS Excel)
• Experience and knowledge with SAP and electronic QMS systems
• Demonstrated communication skills (written / oral) including the ability to read/speak English
• Ability and willingness to work in office and in a production floor setting with moderate noise
• Ability and willingness to work in fast-paced, matrix structured organization
• Willing to work traditional business hours (8am to 5pm) during weekdays (M-F) with the flexibility to accommodate supporting the 24/7 shift schedule

SUMMARY / RESPONSIBILITIES:

• Assist in developing department budget and investment plan(s) according to strategic goals
• Cultivate employee talent through training and coaching measures, while also conducting employee performance reviews
• Support the development and updating of Quality Assurance programs, policies, processes, procedures and controls
• Review, analyze and report on quality discrepancies related to SCHOTT products, while developing disposition and corrective actions for product discrepancies
• Manage the review of batch records and avoid impacting shipment dates
• Manage Department Training Coordinator activities and projects
• Manage document control activities to include, releasing, archiving, tracking and reporting of the document review process for controlled documents
• Lead and support the implementation of Systems and Compliance Improvements including site compliance, along with data integrity requirements
• Measure and analyze Quality System trends
• Oversee the internal audit function to ensure ongoing compliance to the Quality Management System (QMS)
• Maintain the Archive Room and document retention requirements
• Write and revise Standard Operating Procedures (SOPs) and provide training, as required
• Manage the CAPA and Change-Control process to include, issuing, reviewing and approving steps
• Support all customer or registrar quality related audits and/or evaluations
• Utilize quality tools, including Compliant-PRO, etc., for information, tracking and reporting purposes, as required by the Pharm Business Unit
• Manage 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 findings
• Help promote and implement safety/EHS directives and maintain a clean and safe workspace
• Assure compliance with ISO certifications and cGMP, along with adherence to Company policies and procedures and Code of Conduct/safety guidelines