New

Quality Assurance Manager

Schott North America
paid time off, long term disability, tuition reimbursement
United States, Pennsylvania, Lebanon
30 Lebanon Valley Parkway (Show on map)
Jan 12, 2026
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 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 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