Quality Assurance Manager

About us

Your Contribution

• Lead, coach, and motivate employees within respective area of responsibility, while providing direction to achieve department goals and objectives
• 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

Your Profile

• Bachelor’s Degree in Chemistry, Biology, Engineering or science related field, required
• Minimum three years of experience in Quality leadership role
• Solid knowledge of ISO 9001, 14001, 15378, along with cGMP and ISO
• Exposure to the glass forming industry and/or pharmaceutical industry, preferred
• Thorough MS Office applications, SAP and electronic QMS systems
• Multi-tasking abilities
• Decision making
• Detail oriented approach
• Forward/creative thinking
• Service oriented
• Effective communication skills
• Ability to read, write and speak English language

Your Benefits

• Excellent healthcare benefits including medical, dental and vision
• Short and long term disability
• Tuition reimbursement
• Paid time off
• Pet insurance
• Other supplemental benefits available upon election

Please feel free to contact us