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
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