Lead Quality Auditor
New York Blood Center
- Elmsford, NY
- $110,000 per year
- Permanent
- Full-time
- 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. Bachelor’s 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 driver’s license with an acceptable driving record. (preferred)