Posted to MedZilla on 3/21/2019

Takeda Pharmaceuticals

US-MA, Senior QA Specialist Manufacturing Floor Support SR0030953-MZ


Primary Duties
The scope of this role includes direct Quality support of daily manufacturing operations. This position will be a core team member on the QA Operations Floor Support team at Takeda s Lexington, MA facilities and will have direct oversight of routine operations and moderate to complex problem solving. This individual will partner closely with peers in the Manufacturing, Production Technical Services (PTS) and Facilities groups to provide oversight of manufacturing and support function operations.

This individual will be responsible for deploying to the Manufacturing floor to work directly with Manufacturing technicians, ensure a state of continual GMP compliance and review of controlled production records. Ensuring a continuous improvement mindset while ensuring compliance to regulations and standards will be important elements for this position.

This individual will monitors policies, processes, procedures and controls ensuring that the manufacture 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. Close partnership with Manufacturing personnel will be a continual focus of this position. Off-shift work hours may be required by this role.

50% Direct Manufacturing Facility Floor Deployment
25% Controlled production record (Batch record) review
15% Additional oversight responsibilities (Work Orders, Deviation initiation & Review, etc.)
10% Compliance education initiatives and continuous improvement

Education and Experience Requirements
A minimum of a B.S. degree in science or engineering with at least 3-5 years of relevant experience executing, developing and quality oversight to manufacturing operations in GMP biotech or pharmaceutical environments. Prior experience as a Quality professional along with demonstrated quality decision making and leadership is recommended. Knowledge of FDA and EMEA regulations. Skilled at partnering with peers across multiple functions on solutions to moderate to complex issues. Excellent interpersonal skills and the ability to communicate well orally and in writing. The ability to manage multiple competing priorities while demonstrating the ability to work with management across functions on compliant solutions.

Notice to Employment / Recruitment Agents:

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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Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

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