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New York Blood Center · 3 weeks ago

Quality Specialist II

Rye, NY

Full-time

Hybrid

Mid Level

$80K/yr - $90K/yr

4+ years exp

New York Blood Center (NYBC) has served the tri-state area for over 60 years, delivering lifesaving blood products annually. The Quality Specialist II is responsible for ensuring the quality and safety of products and services through the implementation and maintenance of the quality management system, focusing on various program areas.

Health CareMedicalTest and Measurement

H1B Sponsor Likely

Hiring Manager

Leonardo Chavez

Responsibilities

Protects the safety of patients and blood or HCT/P donors by taking immediate action with input from a Quality Manager when there is a critical quality issue that warrants a stop to production and/or delivery of products and services

Contributes to the design and participates in implementation and maintenance of the quality management system, including development, improvement and review of related SOPs, processes, IT solutions, and quality tools as assigned

Independently performs quality assurance activities in support of NYBCe program areas

Ensures that appropriate specifications for NYBCe services and products have been defined according to their intended use

Verifies that products and services consistently meet defined specifications

Confirms that operational SOPs comply with applicable regulations, accreditation standards, and current NYBCe policy

Verifies that document management and record keeping systems comply with regulatory and accreditation requirements

Reviews and approves validation studies for critical processes, equipment, and computer systems to assure that they will consistently perform as expected

Qualifies outside suppliers of reagents, materials and services used in critical processes according to NYBC standards

Assists operational staff in the identification and reporting of deviations and other quality events

Advises and supports operational staff in root cause analysis, and the development of effective corrective action, preventive action, and effectiveness verification plans

Facilitates external regulatory and accreditation inspections, including preparation and follow up activities

Performs record reviews to verify that products/services meet defined specifications prior to release, as assigned

Manages quality events such as adverse events, lookbacks, post-donation information, and complaints

Performs and approves consignee notification and FDA reporting of errors

Independently monitors and assesses quality performance and compliance of operational systems

Manages deviation reporting process, including classification, analysis and follow up

Leads or participates in quality audits

Performs focused quality assessments of operational processes

Tracks, trends, analyzes, and creates reports of quality and process performance data

Contributes to process improvement efforts and facilitates team projects as needed

Advises staff on the development of corrective action and preventive action plans

Performs verification and effectiveness checks for CAPAs

Identifies opportunities for improvement and makes recommendations based on monitoring and assessment activities

Leads or participates in formal process improvement team projects as assigned

Leads or actively participates in regularly scheduled quality management system review meetings with operational staff and managers

Coaches NYBCe staff in GMP and quality principles. Advises staff regarding regulatory and quality issues, and facilitates staff awareness, training, and understanding of applicable regulations. Trains staff in the use of quality tools

Provides Quality and GMP training for new employees, as assigned

Qualification

Quality Management SystemQuality AssuranceRegulatory ComplianceRoot Cause AnalysisProcess ImprovementGMP TrainingASQ CertificationSix Sigma CertificationLean Certification

Required

Bachelor's degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management

Bachelor's degree in another field of study may be considered with strong, relevant work experience

Minimum two years specialized experience (includes performing activities of a quality professional in a healthcare or drugs/biologics/medical devices manufacturing setting)

Minimum four years total relevant experience (includes any combination of: Specialized experience described above, and Clinical or technical work performed in a healthcare, laboratory, or drugs/biologics/medical devices manufacturing setting)

Valid driver's license with an acceptable driving record

Preferred

ASQ, Six Sigma or Lean Certification is a plus

Company

New York Blood Center

New York Blood Center is a blood collection and distribution organization.

Founded in 1964

New York, New York, USA

1001-5000 employees

https://www.nybc.org

H1B Sponsorship

New York Blood Center has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2025 (16)

2024 (17)

2023 (8)

2022 (6)

2021 (6)

2020 (4)