14 days old

Senior Quality Assurance Operations Specialist

Shire Human Genetic Therapies, Inc.
Cambridge, MA 02139
  • Job Code
    R0069537
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 us at Takeda, where you will be the primary quality assurance representative on multiple working teams . You will be empowered to make strategic Quality Assurance decisions. including troubleshooting issues related to quality concerns, implementing solutions and corrective actions. You will follow routine management & coordination of GMP compliance systems and policies for cGMP compliant facilities. Approval of Quality Systems which include deviations and CAPA and supporting disposition while assuring cGMP's and company procedures are followed.

How you will contribute:

  • Knowledge of regulatory requirements and guidelines for US and Europe.
  • Manage complex Quality systems, integrating with existing system.
  • Follow domestic and international GMP regulations, cGMP's, company policies and DNA leadership capabilities.
  • Meet challenging timelines, in spite of obstacles and independently accomplish department goals.
  • When faced with challenging circumstances, finds creative ways to ensure achievement of the desired outcome.
  • You will report into the Director of QA.

Minimum Requirements/Qualifications:

  • B.S. degree in science or relevant experience with in GMP quality programs, biotech and pharmaceutical environments.
  • Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis..

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
  • paid time off for vacation, sick leave, and volunteering
  • Community Outreach Programs and company match of charitable contributions
  • Family Planning Support
  • Professional development opportunities
  • Tuition reimbursement

Important Considerations

At Takeda, our patients rely on us to create quality products and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. 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.

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.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

Following the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

#GMSGQ

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

USA - MA - Alewife - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2022-06-17 Expires: 2022-07-16
Sponsored by:
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Sponsored by:
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Senior Quality Assurance Operations Specialist

Shire Human Genetic Therapies, Inc.
Cambridge, MA 02139

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