Quality Specialist II-Louisville, Kentucky
3 weeks ago
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:
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.
THIS IS A HYBRID POSITION - IN OFFICE 3 DAYS A WEEK
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 (preferred).
Any combination of education and experience equivalent to the requirements listed above has supplied the necessary knowledge, skills, and experience to perform the essential functions of the job equivalent to the job requirements above.
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