Quality Assurance Specialist IIIApply Now Job ID 1601474 Date posted02/23/2017 LocationBrooklyn Park, Minnesota, United States;
- This individual will perform Quality Assurance activities associated with commercial cGMP biologics drug substance manufacture at the Brooklyn Park site of Takeda.
- This person is responsible for review of batch records and associated documentation in support of timely commercial drug substance batch disposition.
- This person provides guidance to site personnel performing deviation investigations, CAPAs and change controls through knowledge of quality concepts, investigational techniques and root cause analysis.
- Performs batch and supporting documentation review thoroughly, with a high attention to detail, using extensive working knowledge of quality concepts and internal procedures and controls.
- Supports GMP compliance with time spent in the Manufacturing environment on a regular basis.
- Analyzes and interprets projects, studies, or investigations to determine next steps. Makes decisions independently and notifies management of action taken.
- Identifies, investigates, and resolves complex technical issues using problem-solving skills. Notifies management of actions taken.
- Reviews deviations, investigations, and CAPAs associated with cGMP compliance. Supports change controls related to Quality topics.
- Writes new documents and revises existing documents, independently.
- Performs QA review/approval of controlled documents.
- Receives minimal supervision on work assignments. Receives overall project direction from management, but completes most work independently.
- Participates in required training and keeps training files current.
- Develops and provides training on department-specific procedures and systems.
- Identifies and proposes Quality Process and system improvements.
- Participates in internal or supplier audits as needed.
- Performs additional duties, as assigned.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
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