US-MA, Senior Quality Assurance Specialist SR0037011-MZ
The scope of this role includes primary QA Contact on quality systems from initiation to closure (deviations, investigations, CAPAs and change controls) that occur at the Lexington site. This individual will partner closely with QA Operations Floor Support peers, Lexington PIER (product Improvement Event Resolution) group and other support functions across the Lexington plant. This position will be a core team member on the QA Technical team and will have direct oversight of moderate to complex quality systems.
This individual is responsible for providing senior level support for issues of moderate complexity. Routine management and coordination of GMP compliance systems and policies for cGMP compliant facilities for bulk drug substance manufacture. Monitors policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations. Demonstrates a high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained. Assures cGMP's and company procedures are followed and, if needed, procedures/policies are revised. Accountable for meeting functional area goals and objectives as they relate to departmental and Takeda goals. Responsible for adhering to GMP regulations, cGMPs, and company policies.
60% - Quality System Support (Deviations, CAPAs, Change Controls)
15% - Document review (procedures/protocols/reports)
15% - Direct manufacturing and/or Quality Control floor walks
10% - Compliance education initiatives and continuous improvement
Education and Experience Requirements
Key Skills, Abilities, and Competencies
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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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