US-MA, Quality Control Senior Analyst - Bioassay SR0031464-MZ
Provide a brief summary describing the major role, responsibilities and purpose of the job. Summarize key areas of accountability and budget responsibility, if applicable.
This position focuses on the daily lab operations and execution of testing to support manufacturing operations, validation, or development studies. Testing typically includes samples from drug substance and drug product manufacturing, stability and various protocol studies using approved test methods. The role may also provide support for sample control activities, and on-call responsibility for critical temperature units.
This position requires competent understanding and ability to perform techniques such as cell-based assays, ELISAs, gels and westerns.
This position is expected to maintain operational and GMP readiness of the QC areas as well as maintain critical reagent inventory such as antibodies and cell banks at business-appropriate quantities. Based on the level of this position, the individual is expected to participate in more complex projects including new product introduction, operational excellence initiatives, and various quality systems (deviations, change controls) with limited supervision.
Education & Experience Requirements
Key Skills and Competencies
Other Job Components
Complexity and Problem Solving
Internal and External Contacts
Routine travel is not expected, but periodic opportunities for training and development may require limited travel.
The following physical abilities are required in order to fulfill the job duties:
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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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