Enterprise Validation Manager - Laboratory - Rhode Island Blood Center

In 1979, the Rhode Island Blood Center was established by the hospitals in Rhode Island as a private, not for profit agency to collect, test, and distribute blood products. Today, the Rhode Blood Center is a division of New York Blood Center and is among the nation's premium providers of blood products and services and an integral part of the Rhode Island community's health care system. As of December 2018, the Rhode Island Blood Center employs approximately 320 full- and part-time employees. Our employees are committed to the Blood Center's mission of providing a safe and adequate blood 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. At the Rhode Island Blood Center, you not only have a job but also the opportunity to make a difference.

For more information about a career with us, please watch the video below:

“Career in Blood” video

This position is responsible for the documentation of software, equipment and or process validations within the regulated Laboratory.  This position is responsible for defining the scope of the projects as well as the execution of test plans to ensure all is working as expected and all regulations are followed.

 Reports to Position:

This position supervises staff.

Supervision of Positions:

Under general supervision of assigned managerial staff.

Primary Duties, Responsibilites or Activities Required by Job:

• Works with the NYBCe Directors, Managers and Supervisors to establish goals and validation plans for changes or additions to laboratory operations
• Coordinates validation and implementation of several key test systems. Act as administrator for laboratory software systems.  Act as administrator of temperature monitor system software.
• Develops validation test plans following FDA guidelines, executes them or oversees their execution by other NYBCe staff members.
• Represents the Laboratory on NYBC Enterprise wide validation projects
• Aide in resolution of technical problems
• Assist in writing and revising SOPs based on operational needs and regulatory requirements.
• Coveys any specific training and procedural needs based on validation outcomes with NYBCe laboratory SOP writers and trainers.
• Recognizes and reports 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.
• Flexes schedule to provide validation management for major lab changes /implementations at all NYBCe laboratory locations
• Participates in clinical trials or ongoing investigational studies of reagents, assays, or equipment.

•  Prepare various reports.

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  Attends conferences, seminars, as required.Makes recommendations to improve business unit practices and processes.
• Any related duties as assigned.
• Follow and enforce the policies of the NYBCe.
• Participate in continuing education and in-service training to meet state and national regulatory requirements.

Education:

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)  Preferred

Hiring Range:  98,000-108,000