Regulatory and Audit Compliance Specialist

Location

Newark, DE | United States

Job description

Founded in 1954, Blood Bank of Delmarva (BBD) is a non-profit, community-based blood center providing blood and blood products to hospitals in the Delmarva region. The Quality and Regulatory Affairs department is responsible for protecting the safety of the donors and patients we serve by ensuring that organizational policies, processes, and practices comply with quality system essentials and regulatory requirements of federal, state, local and industry focused agencies. The department also works with BBD leadership to promote a culture of quality and continuous process improvement. This position is a rewarding opportunity to have a hands-on role in ensuring a safe, effective blood supply for the patients in our community. BBD is FDA licensed, a member of America's Blood Centers, and accredited by AABB.

The Regulatory and Audit Compliance Specialist (“Specialist”) is responsible for developing and maintaining a risk-based quality auditing program for the New York Blood Center Enterprise division. The Specialist monitors and evaluates divisional compliance with regulatory requirements, professional accreditation standards and internal policies and procedures to ensure the ongoing quality and safety of products and services.

• Manages Audits : The Specialist manages the quality audit program for the division, including planning, risk assessment, scheduling, executing, and reporting on audits of the organization’s facilities and operations. The auditor makes recommendations on areas of improvement based on audit observations and findings.
• Advises on Compliance : The Specialist represents the division as a direct liaison to regulators, managing communications, Biologics License Applications (BLA) submissions, regulatory reporting, and ongoing compliance matters, including the filing of Biological Product Deviation Reports (BPDRs). The incumbent serves as a subject matter expert, advising divisional leadership of new or changed regulations and standards, and providing interpretation for successful implementation.
• 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.
• Coordinate external inspections/audits by regulators, accrediting bodies, and customers. Provide guidance on regulatory issues to quality during the inspections, as needed. Collate and review responses to inspection findings and prepare final response report.
• Liaisons with customers, suppliers and regulators as needed to coordinate and manage audit and compliance-related activities.
• Performs quality activities in support of NYBCe divisional 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 NYBCe / divisional policy.
• 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.

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.

  Experience:

• Minimum of 3 years’ experience performing quality audits in a related , highly regulated environment, preferably in the blood, biologics or pharmaceutical industries.
• 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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