US-CA, Sr Quality Analyst Critical Systems Facility Engineering SR0042495-MZ
This position will be part of the QA organization primarily responsible for supporting Critical Systems, Facilities, and Engineering functions at the Los Angeles Facilities. The incumbent will provide quality assurance decisions to daily operations and assure compliance with current GMP, GDDP, GLP, and company procedures. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines, and Takeda Quality practices.
The incumbent will also support facility walkthroughs, continuous improvement initiatives, and compliance projects relating to areas of responsibility. The incumbent will also review and approve Deviations (Level 1) and provide assessments for changes (insignificant and return to operations forms) in accordance with internal procedures and ensure compliance with regulatory requirements. The incumbent will review document changes.
The incumbent will also provide technical knowledge and/or support investigation teams in troubleshooting/problem-solving activities as applicable. Self-led individual that works under only very general supervision to meet deadlines/goals.
Essential Duties and Responsibilities
Education and/or experience
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Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
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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