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The Quality Specialist III of Laboratory Quality position is responsible for performing detailed review of test results and associated data generated by the Alcami Laboratory groups for compliance with cGMP, internal SOPs and Specifications. This position will also support other Quality aspects of the laboratory including equipment qualification, deviation/investigation review and approval, CAPA planning, equipment qualification and SOP review and approvals. The Quality Specialist III must have good organizational skills and be able to manage multiple tasks with competing priority.
The Quality Specialist III is accountable for driving results in a fast-paced environment by effectively performing activities of significant variety and complexity to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting more complex, process-focused audits and inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance training as needed. The position may serve as quality host for client audits and inspections and provide support during regulatory inspections. The position assists with the development of SOPs or other quality documents as needed and may provide guidance and mentoring for other Quality Services employees in areas of expertise. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.
Education and Experience
Alcami Core Leadership Competencies