US-MA, Associate Director Quality Control Microbiology SR0032311-MZ
This position will lead the management and operations of the Quality Control Microbiology Laboratory including support of raw materials, validation, in-process and product testing. In addition, the role provides leadership for developing, maintaining and supporting all aspects of the environmental monitoring and utilities monitoring programs for commercial and clinical drug substance manufacturing.
The Associate Director QC Microbiology directs the work of laboratory management and engages with test and support functions to ensure the timely release of test results.
The position will drive compliance with CGMPs and SOPs and represent the function in the inspection / audit process. In addition, this role will participate in operational excellence initiatives and drive continuous improvement in the microbiology laboratory.
The position requires demonstrated leadership, as well as operational experience in a Quality Control laboratory setting.
60%: Management duties, overseeing cGMP microbiology in support of biologics manufacturing
20%: Regulatory and/or inspection support, initiating/completing quality systems, such as change control or CAPA
20%: Involvement in special projects, such as overseeing and evaluating improvements to LIMS systems and other quality management systems
Education and Experience Requirements
Other Job Requirements
Travel between MA sites may be required.
The following physical abilities are required in order to fulfill the job duties:
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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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