- Protects the safety of patients and blood or HCT/P donors by notifying management and taking immediate action when a critical quality issue is identified that may warrant a stop to production and/or delivery of products and services.
- Monitors and evaluates NYBCe operational systems for quality and compliance with regulatory and accreditation requirements.
- Performs risk assessments.
- Develops annual audit schedule.
- Prepares and communicates audit plans.
- Leads audit teams.
- Prepares written report of audit findings and communicates to auditee.
- Evaluates and approves audit responses.
- Maintains documentation of audit activities.
- Performs follow-up audits as indicated.
- Evaluates critical suppliers for suitability to provide the organization with materials and products of the highest quality and that meet all applicable regulatory and organizational requirements.
- Assists in external inspection readiness activities and provide support during regulatory body inspections and customer audits.
- Liaisons with customers, suppliers and regulators as needed to coordinate and manage audit-related activities.
- Performs quality activities in support of NYBCe program areas.
- Verifies that products and services consistently meet defined specifications .
- Ensures adequate CAPAs are developed in response to audit findings and monitors CAPA closures.
- Confirms that operational SOPs comply with applicable regulations, accreditation standards, and current NYBC policy.
- Qualifies outside suppliers of reagents, materials and services used in critical processes according to NYBCe standards.
- Participates in external regulatory and accreditation inspections, including preparation and follow up activities.
- Contributes to process improvement efforts and leads team projects as needed.
- Identifies opportunities for improvement and makes recommendations based on monitoring and assessment activities.
- Assesses effectiveness of corrective action and preventive action plans.
- Leads or participates in formal process improvement team projects as assigned.
- Actively participates in regularly scheduled quality management system review meetings with operational staff and managers.
- Compiles and reports key performance indicators and compliance status of Quality Audits and GMP Outsourced Activities to Senior Management.
- Authors Standard Operating Procedures, work instructions, forms, templates and other documents associated with the audit process as needed and for periodic review.
- Advises and trains QRA staff in quality auditing principles and techniques. Support the development and maintenance of a qualification program for Quality Auditors.
- Develops and conducts organizational training in regulatory and accreditation requirements and inspection readiness, as assigned.
- Bachelor's degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management. Bachelors degree in another field of study may be considered with strong, relevant work experience.
- Minimum five years experience implementing, interpreting, and providing guidance on U.S. regulations for biologics, or providing quality assurance oversight in blood or biologics industry.
- Minimum three years experience performing quality audits in a related, highly regulated environment, preferably in the blood, biologics or pharmaceutical industries.
- Hybrid workplace with ability to travel up to 50% of time, locally or nationally.
- ASQ American Society for Quality (ASQ) Certified Quality Auditor (CQA) or ISO Lead Auditor certification.
- Experience as an ISO-9000, FACT, CAP or AABB Assessor is a plus.
- Understanding of the manufacture and testing of blood, cellular and gene therapies is desirable.
- Valid drivers license with an acceptable driving record. (preferred)
-
Lead Quality Auditor
4 days ago
New York Blood Center Inc Elmsford, United StatesOverview: · 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. Jo ...
-
Quality Auditor
1 week ago
MAUSER York, United States**Responsibilities**: · - Performs quality assurance testing as required. · - Reviews production orders or schedules to ascertain product data such as types, quantities and specifications of containers to coordinate department operations. · - Observes and records production opera ...
-
Ddsp Quality Assurance Auditor
2 weeks ago
Catholic Guardian Services Bronx, United StatesThe DDSP Quality Assurance Auditor will serve the department's internal audit function by providing **Annual Quality Assurance Reviews (QARs)**and **Quarterly Fiscal Reviews** for Developmental Disability Services Program (DDSP) residences located throughout Staten Island, Queens ...
-
Insurance Premium Auditor/quality Reviewer
2 weeks ago
Sedgwick Danbury, United States**Premium Auditor and Quality Reviewer** · Sedgwick has more than 50 years of experience helping organizations navigate the increasingly complex risk and productivity management environment. We consistently deliver accurate, reliable and timely premium audit results — performing ...
-
Quality Auditor
2 weeks ago
SQA Services New York, United StatesSQA Services is a leading Quality Assurance and Supply Chain consultancy firm. SQA manages Supplier Audit and Supplier Development programs for customers in many industries including Pharmaceutical, Medical Device, Automotive, Aerospace, and Electronics manufacturing. Clients lev ...
-
Quality Auditor
1 week ago
SQA Services Newark, United StatesSQA is a leading Quality Assurance and Supply Chain solutions firm. SQA manages Supplier Audit and Supplier Development programs for clients in quality-critical industries, including Pharmaceutical, Medical Device, Automotive, Aerospace, and Electronics manufacturing. Clients lev ...
-
Quality Auditor
1 week ago
H&H New York, United StatesJob Description · Job DescriptionWe are offering an exciting opportunity for a Quality Auditor in our New York City office. · The Quality Auditor will carry out internal H&H project audits for ongoing design and construction projects. The audits focus on the inspection of the pr ...
-
Quality Auditor
1 week ago
H&H New York, United StatesJob Description · Job DescriptionWe are offering an exciting opportunity for a Quality Auditor to join the H&H Quality Department in our New York City office. · The Quality Auditor will carry out internal H&H project audits for ongoing design and construction projects. The audits ...
-
Coding Quality Auditor-Night
1 week ago
Hackensack Meridian Health Palisades, United States: Our team members are the heart of what makes us better. · At Hackensack Meridian Health we help our patients live better, healthier lives and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitiv ...
-
Supplier Quality Auditor
1 week ago
Lynkx Staffing LLC Saddle Brook, United StatesJob Description · Job Description · Supplier Quality Auditor Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Supplier Quality Auditor ensu ...
-
Supplier Quality Auditor
2 weeks ago
Entegee Allendale, United StatesJob Description · Job DescriptionSummary: Seeking a Supplier Quality Auditor with extensive experience in the Bio/Pharma/cGMP/CDMO industry, auditing proficiency, and certified auditor credentials. · Requirements: · Minimum 5-8 years quality systems auditing experience in pharmac ...
-
Quality Review Auditor
1 week ago
Metropolitan Jewish Health System New York, United StatesThe challenges of affordable healthcare continue to create new opportunities. Elderplan and HomeFirst, our Medicare and Medicaid managed care health plans, are outstanding examples of how we are expanding services in response to our patients' and members' needs. These high-qualit ...
-
Supplier Quality Auditor
1 week ago
Lynkx Staffing LLC Saddle Brook, United StatesJob Description · Job DescriptionSupplier Quality AuditorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Supplier Quality Auditor ensures an ...
-
Quality Assurance Auditor
1 week ago
Nationwide Technical Resources Corp Hicksville, United StatesJob Description · Job DescriptionSeeking a Quality Assurance Auditor for a multi-state food manufacturer to be based in either our NY or KY location. · This position is responsible for auditing the company's plants/suppliers/copackers/warehouse for compliance to both Corporate Q ...
-
Quality Assurance Auditor
5 days ago
Nationwide Technical Resources Corp. Hicksville, United StatesJob Description · Job Description · Seeking a Quality Assurance Auditor for a multi-state food manufacturer to be based in either our · NY or · KY location. · This position is responsible for auditing the company's · plants/suppliers/copackers/warehouse · for compliance to ...
-
Quality Assurance Auditor
1 week ago
City of New York New York, United StatesJob Description · All interested candidates are welcome to apply and will be considered for an interview based on the Minimum Qualification Requirements. Please indicate on your Cover Letter if you are permanent in the civil service title of Assistant Civil Engineer or if you ar ...
-
Quality Assurance Auditor
1 week ago
Patco Brands New York, United StatesPatco Brands is one of the fastest growing beverage companies in the United States. Independently owned, Patco has established itself by using 100% Blue Weber Agave and a proprietary process to innovate within the fast growing ready-to-drink spirits category. · Patco is a maker ...
-
Quality Review Auditor
1 week ago
Metropolitan Jewish Health System New York, United StatesOverview: · The challenges of affordable healthcare continue to create new opportunities. Elderplan and HomeFirst, our Medicare and Medicaid managed care health plans, are outstanding examples of how we are expanding services in response to our patients' and members' needs. Thes ...
-
Quality Review Auditor
1 week ago
MJHS New York, United StatesReq #: · 1805 · Job ID: · 13354 · Job Location: · New York, NY · Zip Code: · 10040 · Category: · Managed Care Nursing · Agency: · Elderplan · Status: · Regular Full-Time · Office: · Office-based · Salary: · $92, $115,345.38 per year · The challenges of affordable healthc ...
-
Auditor Quality Assurance
1 week ago
JetBlue Jamaica, United StatesPosition Summary · The Quality Assurance Auditor is responsible for performing audits as required by Federal Aviation Regulations (FAR The Auditor performs reviews and audits Internal Programs and external business partners' facilities as well as their policies and procedures. · ...
Lead Quality Auditor - Elmsford, NY, United States - New York Blood Center Inc
Description
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:The Lead Auditor will develop and maintain a risk-based quality auditing program harmonized across all NYBCe sites. S/he monitors and evaluates NYBCe compliance with regulatory requirements, professional accreditation standards and internal policies and procedures to ensure the ongoing quality and safety of NYBCe products and services. S/he manages the quality audit program for NYBCe, including planning, risk assessment, scheduling, executing, and reporting on audits of the organizations facilities and operations. The Auditor also plans and executes audits of key suppliers and may coordinate or support audits of NYBCe by clients, regulatory agencies, and accrediting organizations. The lead auditor makes recommendations on areas of improvement based on audit observations and findings.
Education:
Related Experience:
Location Specific Details:
Preferred Qualifications:
Required Licenses / Certification:
For applicants who will perform this position in New York City or Westchester County, the proposed annual salary is $110,000.00 p/yr to $120,000.00 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 applicants skills, job-related knowledge, and experience.
Unless otherwise specified, all posted opportunities are located in the New York or Greater Tri-State office locations
#J-18808-Ljbffr
