The Quality Assurance / Document Control department manages Document Release, Document Change Control, document Approvals, Electronic Document Management System, and records management for Change Control, Deviations/Investigations, CAPA, quality engineering, Complaints, Quality Control, Supplier Quality and continuous improvement activities as well as the review and approval of technical documents.
Duties include inspection of incoming material, dispositioning of non-conforming material, training and leading receiving inspection process improvement, random inspection of Engagement Skills training devices, ISO auditing and in-process inspection of repair shop processes.
As a RN Manager of Clinical Practice & Quality Assurance, you will review all Medicare and other episodic payers clinical records at the local level to assure appropriate documentation for reimbursement.
The Manager QC Raw Materials is responsible for establishing, implementing and maintaining SOPs, laboratory operations and systems supporting raw material specifications, sampling and testing and dispositioning raw materials and components for the Alexion Rhode Island Manufacturing Facility (ARIMF).
The Sr. Manager, QA will manage the development and oversight of the QMS and support the internal and external GLP and GMP activities; establish and maintain an overall Quality System to support clinical cGMP activities.
Assisting in further developing the quality assurance and improvement program to align with industry best practices; conducting and coordinating quality reviews over audit workpapers, audit methodologies and other division processes.
The Quality Assurance Manager provide leadership to develop and implement quality policy and procedures, and manages the quality process. Communicate quality system standards to employees, suppliers and customers.
The Sr. Manager of QA Engineering and Validation is responsible for management and supporting continuous improvement activities associated with Alexion Rhode Island Manufacturing Facility (ARIMF) cGMP compliance of process, equipment, utilities, method and computer system validation, and site inspection readiness.
Responsible for the collection, maintenance and dissemination of federal and state laws, regulations, accrediting agency standards for example CAP, The Joint Commission (TJC), product licenses and resource materials, and the maintenance of regulatory files. Interprets policies as needed to directors and staff.
Review and approve batch records for all labeling and packaging operations; ensure proper version control and document integrity of packaging component labeling, specifications, printed labeling artworks and other assigned labeling documents.