Quality Assurance Specialist II - 2nd or 3rd Shift - United States
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Quality Assurance Specialist II working on the Quality team, you will be empowered to identify and propose system improvements, and a typical day will include:
- Performing Quality Assurance activities associated with commercial cGMP biologics drug substance manufacture at the Brooklyn Park site of Takeda. Second Shift work hours are 2:30pm -11:00pm. Third Shift hours are 11:00pm - 7:30am.
- Reviewing batch records and associated documentation in support of timely commercial drug substance batch disposition.
- Assisting site personnel with deviation investigations, CAPAs and change controls.
- Performs thorough documentation review, with a high attention to detail, using 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 in consultation with Supervisor. Makes basic decisions independently. Reviews more complex decisions with management.
- Assesses deviations assigned a direct root cause, defined CAPAs, and entry-level change controls.
- Revises department-specific controlled documents, independently.
- Participates in required training and keeps training files current.
- Identifies and proposes Quality Process and system improvements.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
BA/BS (or Master's) in any Life Science discipline preferred, and/or 3-5 years experience in Regulated (food, medical device, or pharma/biotech) industry.
- Understands and applies good working knowledge of quality and GMP principles.
- Ability to handle multiple tasks concurrently and in a timely fashion.
- Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
- Must display eagerness to learn and continuously improve.
- Positive work attitude that supports teamwork and continuous improvement.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
- Willingness to travel to various meetings or client sites, including overnight trips
- Requires approximately 0-5% travel
we are driven to improve people's lives
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx
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