Enterprise Validation Manager
4 weeks ago
This role is responsible for the documentation of software, equipment, and process validations within the regulated Laboratory. The successful candidate will define the scope of projects and execute test plans to ensure all systems are working as expected and regulations are followed.
Key Responsibilities
• Work with NYBCe Directors, Managers, and Supervisors to establish goals and validation plans for changes or additions to laboratory operations
• Coordinate validation and implementation of several key test systems, act as administrator for laboratory software systems, and administer temperature monitor system software
• Develop validation test plans following FDA guidelines, execute them, or oversee their execution by other NYBCe staff members
• Represent the Laboratory on NYBC Enterprise-wide validation projects
• Assist in writing and revising SOPs based on operational needs and regulatory requirements
• Recognize and report to management any problems encountered during performance of job tasks, including equipment malfunction, deviation from standard operating procedure, unusual results, and discrepancy in test controls or controls outside established normal limits
Requirements
• Bachelor's degree in Chemistry, Biology, or related field
• 4 years of experience in a laboratory setting focusing on writing and executing validation processes
• Medical Laboratory Scientist with National Certifications (MLS, BB, or SBB)
About Us
The Rhode Island Blood Center is a division of New York Blood Center and is among the nation's premium providers of blood products and services. As a committed team, we strive to provide a safe and adequate blood supply for patients within our community. We seek individuals who are caring and compassionate, who take pride in their work, and are looking for a rewarding experience.
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