Sterile Products Quality Assurance Specialist
2 days ago
About SCHOTT North America, Inc.
Schott is a leading international technology group in the areas of specialty glass, medical and optical systems. The company has a global presence with more than 15,000 employees, headquarters in Mainz (Germany) and branches in 35 countries. Our North American operations are headquartered in Elmsford, New York.
We currently have an exciting opportunity for a skilled Sterile Products Quality Assurance Specialist to join our team at our manufacturing facility in Alzenau, Germany or another location as agreed upon during the hiring process.
About the Role:
- Perform validation and re-validation of sterilization processes to ensure compliance with regulatory requirements.
- Lead regional or customer-led improvement activities/roll-outs to optimize quality and efficiency.
- Trend and monitor KPIs pertaining to Sterile products to drive continuous improvement.
- Assure compliance with ISO and cGMP regulations through regular audits and inspections.
- Support the laboratory side of engineering through method and equipment validation/qualification initiatives.
- Manage and trend data from EM process, raw materials, and finished product testing related to Sterile products.
- Conduct risk assessments to identify potential hazards and implement mitigating measures.
- Lead process mapping and continuous improvement activities to streamline operations.
- Monitor and support the proper implementation of change controls to maintain quality standards.
- Support quality control plan analysis and improvements to ensure adherence to regulatory requirements.
- Coordinate, collect, and analyze quality data for customers; troubleshoot and resolve customer issues.
- Manage assigned CAPAs to ensure timely resolution and closure.
- Support experimental and validation protocols for equipment, processes, and materials.
About You:
- Bachelor's Degree in Chemistry, Microbiology, or a related field, required.
- Minimum (5) years of experience within a Quality Engineer role with sterile products, preferred.
- Minimum (3) years of experience in product/process investigations, validations, instrument qualifications, and EM programs, required.
- Solid knowledge of ISO 9001, 13485, and 15378, along with cGMP, preferred.
- Experience in glass forming industry and/or pharmaceutical industry, preferred.
- Sound computer knowledge and skills, including MS Office, SAP, and Minitab, required.
What We Offer:
- An estimated annual salary of €80,000 - €110,000 depending on experience and qualifications.
- A comprehensive benefits package, including excellent healthcare benefits, short and long-term disability, tuition reimbursement, pet insurance, paid time off, and other supplemental benefits available upon election.
- A dynamic and inclusive work environment that values equity, diversity, and inclusion.
- Opportunities for professional growth and development in a rapidly evolving industry.
- The chance to work with a leading international technology group in the areas of specialty glass, medical, and optical systems.
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