Perform Quality Systems activities associated with commercial cGMP biologics drug substance manufactured at Takeda Brooklyn Park.
Be a primary Business Administrator and Subject Matter Expert (SME) for Takeda’s Electronic Quality Management System.
Support quality management procedures and provide targeted technical training (e.g., deviation, CAPA, change management).
Improve completion of deviations, CAPAs and change requests with metrics reporting and collaboration.
Report metrics on health of the business as it relates to Quality Systems.
Assist site personnel performing deviation investigations, CAPAs, and change controls.
Perform documentation review thoroughly, using working knowledge of quality concepts and internal procedures and controls.
Support GMP compliance with time spent in the Manufacturing environment.
Analyze projects, studies, or investigations to determine next steps with management. Make basic decisions independently. Review more complex decisions with management.
Resolve basic technical issues using problem-solving skills with management.
Assess deviations assigned a direct root cause, defined CAPAs, and entry-level change controls.
Revise department-specific controlled documents independently.
Receive specific instruction on new assignments.
Identify and propose Quality Process and system improvements.
Complete mandatory training within required timeframe.
Perform additional tasks, as assigned, including support of Compliance and Supplier Quality functions.
BA/BS (or Master’s) in any Life Science discipline preferred, and 3+ years’ experience in Regulated (food, medical device, or pharma/biotech) industry.
Understand and apply knowledge of quality and GMP principles.
Familiarity or experience with the following : DMAIC investigation process; Root Cause Analysis; basic statistics; Peer approval of documentation; Quality Training; Quality Improvement Tools (Risk Assessments, flowcharts, metrics generation); Technical Writing and Review; Write and review investigations.
ASQ Certified Quality Auditor (CQA) or other certification.
What Takeda can offer you:
Comprehensive Healthcare: Medical, Dental, and Vision.
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan.
Health & Wellness programs including onsite flu shots and health screenings.
Generous time off for vacation and the option to purchase additional vacation days.
Community Outreach Programs and company match of charitable contributions.
Family Planning Support.
Professional development opportunities.
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. You may:
Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet, and body. This may include additional hearing protection for loud areas.
Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This posting excludes Colorado applicants.
#GMSGQ #ZR1 #LI-MA1
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Brooklyn Park, MN