Posted in Information Technology 30+ days ago.
Type: Full-Time
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Join Takeda as a Senior Specialist QA Disposition where you will work with other Quality Disposition professionals on batch disposition of biologics. You will also work with our CMO partners evaluating their processes. As part of the Biologics External Supply Quality Disposition team, you will report to the Head of Quality Disposition for the U.S. and work with Quality teams and with external supply, planning, technical and other partners including CMO partners to disposition batches.
You will lead continuous improvement programs in the batch disposition team and support continuous improvement projects in Biologics external supply
Evaluate CMO's Quality Management Systems to ensure appropriate level and content of reporting, including technical evaluation of quality system reports
Review batch manufacturing records to determine assurances of safety, identity, strength, quality, or purity
Determine impact of production / release schedule changes to commercial supply
Evaluate Takeda's batch review / release systems to ensure efficient processes are implemented with integrated continuous improvement methodologies
Facilitate and provide inputs into deviation investigations, change controls, CAPA, investigations and nonconformance reviews
6+ years' experience working in manufacturing or Quality to support the manufacturing of biologic products.
Experience with quality systems and cGMPs.
Experience conducting audits or involvement in preparation for Health Authority inspections.
Must be fluent in English
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
Flexible Work Paths
Tuition reimbursement
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will 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.
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.
EEO Statement
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.
Full time
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