US-CA, Sr Quality Associate B8 SR0046380-MZ
Shift 2 (Swing): This position reports to Swing (2) shift. This shift schedule is Monday-Friday from 2:00 PM to 10:00 PM. This shift requires working on all company designated holidays. Due to business need, on select occasion employees may be required to work overtime and/or support operations on an alternate shift.
Summary: Successfully perform all the primary activities as defined in the QA I and QA II job positions.Handle multiple projects.Demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem-solving, and team leadership.Lead PMT, QWT, Kaizen or equivalent focus type group activities as required. Utilize standard engineering principles to implement quality engineering solutions in EBM, Delta V and other electronic systems, evaluation, selection and adaptation of various engineering techniques, constructing detailed, accurate project schedules, interfacing with development groups and technical support groups. Devise new approaches to complex problems through adaptations and modifications of standard technical principles. Support in implementation of standard engineering assignments which are typically a significant portion of cGMP, Quality and Compliance. Select cGMP, Quality and Compliance sound techniques to solve problems and CAPAs. Design, lead and perform experiments using sound scientific principles.Provide ownership and oversight of the user Intervention system.A functional understanding of FDA CFR; EMA - EUDRALEX, ISO, and Takeda Quality Systems is also required. Additionally, oversee and support Building 8 Ramp Up activities.
Essential Duties and Responsibilities:
Education and/or experience:
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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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