Talent.com
Quality Specialist II
Quality Specialist IINew York Blood Center • Rye, NY, United States
[error_messages.no_longer_accepting]
Quality Specialist II

Quality Specialist II

New York Blood Center • Rye, NY, United States
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Quality Specialist II

Job Locations

US-NY-Rye

Job ID

2025-7777

Category

Quality

Minimum Rate

USD $80,000.00 / Yr.

Maximum Rate

USD $90,000.00 / Yr.

Work Location Type

Physical

Responsibilities

The Quality Specialist II works to ensure the quality and safety of products and services by applying knowledge of quality principles and practices to the design, implementation, control, monitoring, assessment, and continuous improvement of work processes.

The incumbent participates in the implementation and maintenance of the quality management system (QMS), with a focus on one or more program areas, including collection of 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.

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.
  • Qualifications

    Education :

  • 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.
  • Related 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).
  • Preferred Qualifications :

  • ASQ, Six Sigma or Lean Certification is a plus.
  • Required Licenses / Certification :

  • Valid driver's license with an acceptable driving record.
  • For applicants who will perform this position in New York City or Westchester County, the proposed annual salary is $80,000.00 p / yr. to $90,000.00 p / yr. For applicants who will perform this position outside of New York City or Westchester County, salary will reflect local market rates and be commensurate with the applicant's skills, job-related knowledge, and experience.

    Unless otherwise specified, all posted opportunities are located in the New York or Greater Tri-State office locations.

    Overview

    Founded in 1964, New York Blood Center (NYBC) has served the tri-state area for more than 60 years, delivering 500,000 lifesaving blood products annually to 150+ hospitals, EMS and healthcare partners. NYBC is part of New York Blood Center Enterprises (NYBCe), which spans 17+ states and delivers one million blood products to 400+ U.S. hospitals annually. NYBCe additionally delivers cellular therapies, specialty pharmacy, and medical services to 200+ research, academic and biopharmaceutical organizations. NYBCe's Lindsley F. Kimball Research Institute is a leader in hematology and transfusion medicine research, dedicated to the study, prevention, treatment and cure of bloodborne and blood-related diseases. NYBC serves as a vital community lifeline dedicated to helping patients and advancing global public health. To learn more, visit nybc.org. Connect with us on Facebook, X, Instagram, and LinkedIn.

    [job_alerts.create_a_job]

    Quality Specialist Ii • Rye, NY, United States

    [internal_linking.related_jobs]
    Senior Quality Specialist II, GCP / PV / REMS Quality

    Senior Quality Specialist II, GCP / PV / REMS Quality

    Purdue Pharma • Stamford, CT, United States
    [job_card.full_time]
    We were founded by physicians, and we are currently led by a physician.Beyond our efforts to provide quality medications, Purdue is committed to supporting national, regional and local collaboratio...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Build Quality Engineer II

    Build Quality Engineer II

    Relativity Space • Long Beach, New York, USA
    [job_card.full_time]
    At Relativity Space were building rockets to serve todays needs and tomorrows breakthroughs.OurTerran R vehicle will deliver customer payloads to orbit meeting the growing demand for launchcapacity...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Director, Ob / Gyn Quality & Safety - NewYork-Presbyterian / Queens

    Director, Ob / Gyn Quality & Safety - NewYork-Presbyterian / Queens

    NewYork-Presbyterian • Queens, US
    [job_card.full_time]
    Department of Obstetrics and Gynecology is looking for a Board Certified .Director of Ob / Gyn Quality & Safety.This position incorporates inpatient & outpatient clinical work as well as...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Customer Support Quality Lead

    Customer Support Quality Lead

    VirtualVocations • Jamaica, New York, United States
    [job_card.full_time]
    A company is looking for a Customer Support Quality Lead to enhance customer support interactions.Key Responsibilities Establish and improve a QA program for evaluating agent performance across s...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    AP Specialist

    AP Specialist

    CFS • Brewster, NY, US
    [job_card.full_time]
    Our client, a reputable and growing company in.This is a fast-paced, hands-on role with strong visibility across the organization. You'll manage key AP functions while supporting inventory reconcili...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Epic Beaker Analyst

    Epic Beaker Analyst

    Medisys Health Network, Inc. • Hicksville, NY, US
    [job_card.full_time]
    Serve as an active member of the Beaker clinical application team, dedicated to the full implementation roll-out, transitioning from Soft Lab (SCC) to Epic Beaker. Play a crucial role in the impleme...[show_more]
    [last_updated.last_updated_30] • [promoted]
    R&D Sr Specialist

    R&D Sr Specialist

    Axelon Services Corporation • Valhalla, NY, US
    [job_card.full_time]
    Team : Global R&D Flavor Specifications Were seeking a contractor to support flavor ingredient specifications for global beverage applications. This role focuses on documentation, testing coordinatio...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Service Technician I

    Service Technician I

    Securitas Electronic Security • Queens, New York, United States
    [job_card.full_time]
    Securitas Technology Corporations is a division of Securitas AB, the largest protective services provider in the world with over 370,000+ Securitas Heroes across the world.STC offers a full portfol...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Quality Inspection Specialist II

    Quality Inspection Specialist II

    Vast • Long Beach, New York, USA
    [job_card.full_time] +1
    At Vast our mission is to contribute to a future where billions of people are living and thriving in space.We are building artificial gravity space stations allowing long-term stays in space withou...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Quality Specialist II

    Quality Specialist II

    New York Blood Center • Rye, NY, United States
    [job_card.full_time]
    Quality Specialist II Job LocationsUS-NY-Rye Job ID2025-7777 CategoryQuality Minimum RateUSD $80,000.Work Location TypePhysical Responsibilities. The Quality Specialist II works to ensure the qualit...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Manager II, QA

    Manager II, QA

    Thumbtack • Hempstead, NY, US
    [job_card.full_time]
    Thumbtack helps millions of people confidently care for their homes.Thumbtack is the one app you need to take care of and improve your home from personalized guidance to AI tools and a best-in-cla...[show_more]
    [last_updated.last_updated_30] • [promoted]
    HR Data and Systems Specialist

    HR Data and Systems Specialist

    InsideHigherEd • Hempstead, New York, United States
    [job_card.full_time] +1
    Hofstra University is nationally ranked and recognized as Long Island’s largest private university located in Hempstead, N. When you work at Hofstra, you join a team of talented professionals commit...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Vice President of Quality, Behavioral Health

    Vice President of Quality, Behavioral Health

    Northwell Health Physician Partners • Queens, US
    [job_card.full_time]
    Young, Chair and Senior Vice President of Behavioral Health and Dr.Manish Sapra, Executive Director of Northwell Health’s Behavioral Health Service Line, with the support of Northwell Executive Lea...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Director, Ob / Gyn Quality & Safety - NewYork-Presbyterian / Queens

    Director, Ob / Gyn Quality & Safety - NewYork-Presbyterian / Queens

    HealthEcareers - Client • Queens, NY, USA
    [job_card.full_time]
    Department of Obstetrics and Gynecology is looking for a Board Certified .Director of Ob / Gyn Quality & Safety.This position incorporates inpatient & outpatient clinical work as well as administrati...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Office Engineer (MTA)

    Office Engineer (MTA)

    SI Engineering, P.C. • Brewster, NY, US
    [job_card.full_time]
    Join a Team That Builds New York.We are seeking a detail-oriented, proactive.The Office Engineer will serve as a critical liaison between the field construction team, project management, subcontrac...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Quality Assurance Supervisor - Sanitation

    Quality Assurance Supervisor - Sanitation

    LSG Sky Chefs • Queens, NY, US
    [job_card.full_time]
    Job Title : Quality Assurance Supervisor - Sanitation .LSG Sky Chefs is one of the world's largest airline catering and hospitality providers, known for its outstanding reputation and dynamic approa...[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    Supervisor, Clinical Laboratory Operations - Histology

    Supervisor, Clinical Laboratory Operations - Histology

    Northwell Health • Mount Kisco, NY, United States
    [job_card.full_time]
    Supervises and coordinates the staff and daily activities of staff in a laboratory.Promotes Clinical Laboratory Operations' department goals by selecting,. Leads the activities of assigned Clinical ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Manager, Site Safety-Production Center

    Manager, Site Safety-Production Center

    libertycoke • Elmsford, NY, USA
    [job_card.full_time]
    Working at Liberty Coca-Cola Beverages LLC is all about pursuing a career not just a job.Discover what it means to be energized by a multitude of possibilities and a dynamic team.At Liberty Coca-Co...[show_more]
    [last_updated.last_updated_30] • [promoted]