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 plans 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 CAPAs 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 and 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
Bachelors 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.
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.
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Job Segment: Pharmaceutical QA, Quality Assurance, Document Control, Science, Technology, Quality, Customer Service, Administrative