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Quality Assurance Specialist II

Peabody, Massachusetts
Remote Working
Remote Working
Job Type
17 Sep 2022

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Job Description

Quality Assurance Specialist II About the role:

You will be empowered to make strategic Quality Assurance decisions including troubleshooting issues related to quality concerns, implementing solutions and corrective actions. You will report to Quality Assurance Manager,

How you will contribute:
  • Will perform functions observing cGMP guidelines. Knowledge of regulatory requirements and guidelines for US and Europe.
  • You will create complex Quality systems, integrating with existing systems
  • Observe domestic and international GMP regulations, cGMP's, company policies and company leadership expectations.
  • You will meet challenging timelines, in spite of obstacles.
  • Understand the needs of main collaborators and customers, and interact intra- and interdepartmentally to ensure agreement and agreement.
  • Can develop and promoting sound QA systems' approaches and principles.
  • Demonstrate unwavering ethics and respect for all customers. Practice, building authentic relations. You will need to embrace change.
  • When faced with challenging circumstances, finds creative ways to ensure achievement of the desired, compliant outcome.
  • Plan, organizes and communicates with others who may have concurrent work streams, improve customer service and demonstrate genuine respect for others.
  • It is incumbent upon you to bring any concerns to direct supervisor or areas of disagreement to supervisor.
  • Receive general instructions on new work; refer to policies for guidance. Work is reviewed for technical soundness and accuracy.
Minimum Requirements/Qualifications:
  • A minimum of a B.S. degree in science or engineering with at least 3 years relevant experience developing, and administrating GMP quality programs in cGMP biotech or pharmaceutical environments.
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 training 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.
  • Work in a cold, wet environment 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 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.

You will be classified as "hybrid" following Takeda's Hybrid and Remote Work policy.

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


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.


USA - MA - North Reading - BIO OPS

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Time Type

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  • Job Reference: 714824177-2
  • Date Posted: 17 September 2022
  • Recruiter: Takeda Pharmaceutical
  • Location: Peabody, Massachusetts
  • Remote Working: Some remote working possible
  • Salary: On Application
  • Sector: Healthcare & Medical
  • Job Type: Permanent