| POSITION SUMMARY:
Under limited supervision and with a solid understanding of science and technology, monitors operations and develops and manages quality improvement initiatives to ensure that systems are safe, effective, appropriate, compliant, current, and adhered to by staff for the company’s North American operations. ESSENTIAL FUNCTIONS: - Support the organization in monitoring the compliance of laboratory testing, manufacturing, and clinical research, and ensuring continued effectiveness of the QMS according to CLIA, CAP, HIPAA, GLP, GMP, and QSR requirements.
- Serve as a backup to the Quality site head as necessary which can include attending site meetings to represent Quality, providing guidance to operations in matters of regulatory compliance, and keeping site and departmental leadership informed of critical events.
- Represent the Quality unit on cross-functional project teams.
- Prepare, maintain, analyze, and present metrics related to the quality or analytical systems.
- Manage and maintain programs within the Quality Management System as assigned by the Quality site head, which could include but are not limited to audit, change control, and/or supplier quality programs.
- Lead and/or support internal audits, client audits, supplier audits, and regulatory audits including, but not limited to: audit scheduling, audit preparation, audit execution, audit response/resolution, and audit follow-up.
- Assist in integration efforts and ensure a consistent approach across all company sites wherever possible.
- Participate in the general Quality Department oversight activities associated with non-conformances, complaints, lot release, change management, document control, training, equipment management, and other duties as assigned.
- Communicate effectively with internal personnel, as well as external customers and suppliers.
- Collaborate effectively and positively within department and all other company departments.
- Represent department and the organization favorably and in accordance with established Company standards.
- Follow all company safety policies & other safety precautions within the work area.
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