NCBiotech Jobs Board ● Connecting North Carolina's life science employers and workforce.
The Senior Quality Specialist is accountable for driving results in a fast-paced environment by effectively performing activities of substantial variety and complexity to ensure quality and compliance with applicable regulatory requirements and is proficient in all document and protocol approvals applicable to the respective processes executed at the respective lab or manufacturing facility. These activities include reviewing documents and data, conducting 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 serves as quality host for client and regulatory agency audits and inspections. The position develops SOPs or other quality documents as needed. The position provides guidance and mentoring for other Quality employees. Serve as a back-up to site Quality Management for technical Quality decision making. 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
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