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Quality Specialist I

Overview
At New York Blood Center, one of the most comprehensive blood centers in the world, our focus is on cultivating excellence by merging cutting-edge innovation with diligent customer service, groundbreaking research, and comprehensive program and service development. Join us as we work towards meeting and exceeding the growing needs of our diverse communities, further our lifesaving strategic goals in a rapidly changing environment, and expand our impact on the local, national, and global communities we serve.
Responsibilities
As a key member of our team, the Quality Specialist I, will work to ensure the quality and safety of NYBC products and services by applying knowledge of quality principles and practices to the design, implementation, control, monitoring, assessment and continuous improvement of work processes. In addition, you will participate in the implementation of the quality management system (QMS), with a focus on one or more program areas, including blood and cellular therapy products manufacturing and distribution, clinical services, transfusion services, laboratory services, and clinical research, as well as organization-wide support functions such as information systems, facilities and safety.
Responsibilities include:
Performing quality assurance activities in support of NYBC program areas
Participating in the implementation of our Quality Management System, including the development, improvement, and review of SOPs, processes, IT solutions, and quality tools
Ensuring that appropriate specifications for NYBC services and products have been defined according to their intended use, and verifies that they consistently meet these defined specifications
Confirming that operational SOPs comply with applicable regulations, accreditation standards, and current NYBC policy
Verifying that document management and record keeping systems comply with regulatory and accreditation requirements
Reviewing validation studies for critical processes, equipment and computer systems to assure that they will consistently perform as expected
Assisting operational staff in root cause analysis, and the development of effective corrective action, preventive action, and effectiveness verification plans
Providing support for external regulatory and accreditation inspections, including preparation and follow up activities
Monitoring and assessing quality performance and compliance of operational systems
Tracking deviation reporting process, including classification, analysis, follow up and reports quality and process performance data
Performing verification and effectiveness checks for CAPAs
Assisting in training NYBC staff in GMP and quality principles and in the use of quality tools
Implementing and monitoring environmental health and safety activities
Handling other related functions as necessary
Qualifications
To qualify, you must have a Bachelor's Degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management, along with at least two years of specialized experience as a quality professional in a healthcare or drugs/biologics/medical devices manufacturing setting, or handling clinical or technical work performed in a healthcare, laboratory or drugs/biologics/medical devices manufacturing setting. Working knowledge of QA methods, principles, and practices, including basic statistical analysis and sampling techniques, auditing, process control, validation and process improvement methodologies will be expected, as will knowledge of regulations and accreditation standards applicable to the NYBC program units supported, including blood and tissue establishments, and clinical laboratories. Understanding of Federal, State, Local and International regulations and standards, technical specifications, and other guidelines to evaluate compliance, along with superior analytical, oral/written communication, investigative, problem-solving and decision-making skills are a must.

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