Job Summary
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The Healthcare Quality Assurance (QA) Supervisor-Pozzuolo Martesana BOMI Site communicates the quality policy and objectives to help ensure the maintenance of the overall healthcare compliance for the operation/department. The successful candidate will advise on development of standard operating procedures (SOPs), review and approve client and facility work instructions, train QA personnel and internal clients on SOPs and regulatory topics, and oversee the maintenance of the quality documents. This position participates in internal, client, and agency audits, and follows up on audit outcomes. The HC Quality Assurance Supervisor maintains knowledge of healthcare quality and regulatory requirements and assesses and addresses risks associated with transporting healthcare and food products. Manage GMP Quarantine Site as Qualified Person, manage as GDP responsible person what around distribution.
Responsibilities
Monitors and instructs for compliance with UPS HC site license requirements.
Promotes issue resolution, risk management, continuous improvements, and project initiatives.
Facilitates, hosts, and responds to audits (Internal, Regulatory Agencies and Clients).
Assists with creation, revision, and approval of Controlled Documents (SOP/WI/Forms).
Provides investigation and non-conformance reporting, including development of proactive strategies to prevent recurrence.
Controls changes management.
Provides quality and regulatory compliance guidance to clients and internal staff.
Supports growth of new and expanded facilities, clients and services.
Participates in environmental control and CDS security emergency response action team.
Performs direct report responsibilities (risk assessment, task delegation, performance evaluation, skill development, constructive feedback, formal performance review, formal career development).
Qualificati