Posted to MedZilla on 8/17/2019


Takeda Pharmaceuticals

US-MA, Sr QC Specialist I SR0037479-MZ


 
 

Primary Duties

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:

  • Scheduling Raw Material activities
  • Contract lab testing submission and tracking
  • Material specification management
  • Document revisions
  • Raw Material data review
  • Continuous improvement initiatives
  • Generation & Analysis of department metrics

Responsibilities:

60%

  • Plan/schedule key activities needed for release of raw material times.
  • Data analysis, project and testing coordination, support of material specification management, COA generation, material specification creation, document revisions.

25%

  • Regulatory and/or inspection support, method projects activities, initiating/completing quality systems.
  • Drive process improvement for the value stream through identification and remediation of bottlenecks in the raw material release process.
  • Collaborate with site Operational Excellence to utilize standard tools to progress and evolve performance through both initiative and project work.
  • Ensure lean principles are being effectively utilized in the value stream process as evidenced by waste removal and throughput improvement over time.
  • Provide recommendations on opportunities to eliminate waste.

15%

  • Involvement in other QC activities as required
  • Provide support to ongoing site project work that is centered on improving the business.
  • Utilize project management tools to deliver improvements on-time and in-full

Education and Experience Requirements

Essential:

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.

Desired:

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.

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.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

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.


Please visit our website at takedajobs.com

 
 


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