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The Cleanroom & HEPA Certification Specialist will manage preventive maintenance and certification activities for Cleanroom environments and equipment, coordinate with vendors for certifications, maintain documentation, analyze data, and ensure compliance with SOPs and quality standards.
The Supervisor of Quality Assurance is responsible for overseeing product and raw material disposition, ensuring compliance with quality assurance policies, and leading investigations and evaluations related to process deviations. This position requires supervising direct reports and engaging in continuous improvement efforts.
Design, implement, and support Data Acquisition and Analysis Systems. Troubleshoot manufacturing deviations and anomalies. Develop engineering design documents and test plans. Support manufacturing, engineering, and validation projects. Author system specifications and execute acceptance tests. Review cyber security vulnerabilities. Create and maintain automation system documentation.
The Senior Manager Accounting will manage the Inventory Accounting team, oversee monthly reporting of inventory results, handle profit in inventory elimination, maintain the inventory and standard cost system, review audits, ensure adherence to Sarbanes Oxley, and collaborate with corporate accounting. Strong management and analytical skills are essential, along with proficiency in Oracle applications and Microsoft Excel.
The Senior Process Scientist heads lifecycle activities associated with in-process control (IPC) programs for manufacturing biologics. This includes data analysis, regulatory documentation support, and interdepartmental facilitation. Responsibilities also involve applying statistical process control tools and completing IPC documentation related to batch production.
As a System Administrator (IT Applications), you will configure, implement and maintain various IT applications and systems, support production systems, assist in troubleshooting, handle documentation, and collaborate with cross-functional teams to enhance system functionality while ensuring compliance with IT standards.
The Associate Manager Quality Compliance oversees Quality and Compliance at the site level, ensuring adherence to regulatory requirements and site expectations. Responsibilities include managing quality systems, reviewing documents, participating in audits, and training personnel, while driving continuous improvement initiatives.
The Principal Quality Systems Specialist ensures compliance with quality regulations and guidelines at the Raheen site, overseeing QMS implementation and leading continuous improvement initiatives. Responsibilities include reviewing quality documents, collaborating with teams to resolve compliance issues, training personnel, and participating in audits.
The Process Specialist Downstream role involves providing technical support for manufacturing processes, facilitating technology transfer, writing and reviewing procedures, and resolving process-related issues. The position requires collaboration with multiple departments to implement improvements and ensure compliance with safety and quality standards.
The Senior Workplace Coordinator manages workplace strategy projects, providing support for planning, procurement, and installation of lab equipment and furniture. Responsibilities include coordinating day-to-day activities, maintaining budgets, facilitating communication between departments, and managing vendor relations to ensure efficient project execution with minimal disruption.
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