Quality Specialist II

2 weeks ago

City of Rye, United States New York Blood Center Full time

Overview Quality Specialist II role at New York Blood Center . Founded in 1964, New York Blood Center (NYBC) has served the tri-state area for more than 60 years, delivering lifesaving blood products and related services to hospitals, EMS, and healthcare partners. NYBC is part of New York Blood Center Enterprises (NYBCe), with activities across multiple states and services. Learn more at nybc.org. Responsibilities Works to ensure the quality and safety of products and services by applying quality principles to the design, implementation, control, monitoring, assessment, and continuous improvement of work processes. Participates in implementing and maintaining the quality management system (QMS), focusing on one or more program areas (collection of blood and cellular therapy products, manufacturing and distribution, clinical services, transfusion services, laboratory services, clinical research) and organization-wide support functions (information systems, facilities, safety). Protects patient and donor safety by taking immediate action with input from a Quality Manager when a critical quality issue warrants stopping production or delivery of products or services. Contributes to the design, implementation, and maintenance of the QMS, including development, improvement, and review of SOPs, processes, IT solutions, and quality tools. Independently performs quality assurance activities in support of NYBCe program areas. Manages deviation reporting, audits, CAPAs, recordkeeping, supplier qualification, and regulatory/quality inspections as assigned. Supports operational staff in root cause analysis and the development of corrective action, preventive action (CAPA) plans and verification of effectiveness. Facilitates external regulatory and accreditation inspections and related follow-up activities. Monitors and assesses quality performance and compliance of operational systems. Leads or participates in quality improvement projects and team activities; provides training on GMP and quality principles as needed. Qualifications Education: Bachelor's degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management. Bachelor’s degree in another field may be considered with strong, relevant work experience. Related Experience: Minimum two years of specialized experience in a healthcare or drugs/biologics/medical devices manufacturing setting (quality professional activities). Minimum four years total relevant experience (combining specialized experience and clinical/technical work in healthcare, laboratory, or related manufacturing settings). Preferred Qualifications: ASQ, Six Sigma, or Lean Certification is a plus. Required Licenses / Certification: Valid driver’s license with an acceptable driving record. Salary details: For applicants in NYC/Westchester, $80,000 to $90,000 per year; outside NYC/Westchester, salary will reflect local market rates and be commensurate with skills and experience. Posted opportunities are located in New York or Greater Tri-State office locations unless specified otherwise. Job details Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industries: Hospitals and Health Care Note: This post includes additional job postings and salary ranges for related roles in the area. #J-18808-Ljbffr

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