US-MA, Sr QC Specialist I SR0037479-MZ
Sr QC Specialist I is responsible for the planning and scheduling of raw material activities from inspection, sampling and testing to optimize throughput and support manufacturing demand in the most efficient fashion. This role assumes the primary responsibility for ensuring lot inspection/release is defined as standard work, and tracking performance to that standard.
Primary activities would generally include but not limited to:
Education and Experience Requirements
A minimum of a B.S. degree in science or engineering with at least 5-10 years relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments is preferred.
Knowledge of FDA and EMEA regulations pertaining to materials management and control, as well as a working knowledge of root cause analysis. Knowledgeable of USP, EP and JP compendia.
Excellent interpersonal skills and the ability to communicate well orally and in writing.
Direct Biologic Pharmaceuticals Raw Material experience within Technical Operations
Other Job Requirement
Must be flexible to work late shifts and weekends on ad-hoc basis, primarily during regulatory agency inspections, priority assignments, and product launch activities.
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Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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