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Sr Specialist QA Disposition at Shire Human Genetic Therapies, Inc. in Lexington, Massachusetts

Posted in Information Technology 30+ days ago.

Type: Full-Time





Job Description:

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role:

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.

How you will contribute:


  • 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


What you bring to Takeda:


  • 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


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


  • Flexible Work Paths


  • Tuition reimbursement


More about us:

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.

Empowering our people to shine:

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.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





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