19 days old

Senior Quality Assurance Validation Specialist I

Shire Human Genetic Therapies, Inc.
Cambridge, MA 02139
  • Job Code
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Job Description

Senior Quality Assurance Validation Specialist I

About the role:

Join Takeda as a Senior Quality Assurance Validation Specialist where you will provide quality oversight and ensure GMP compliance for engineering and validation deliverables related to site projects (Compliance, Improvement, Technology Transfers) including requirements definition, specification, engineering design, qualification, cleaning and manufacturing process validation, and change management.. You will also provide support during internal and agency inspections and performing quality assessment for all site-based engineering changes.. As part of the Quality Assurance Validation team, you will report to Manager of Quality Assurance and work with a variety of teams within the facility.

How you will contribute:

  • You will be contact for customer groups to identify project needs and ensure practices are consistent with quality and regulator standards
  • You will support site validation maintenance activities and continuous improvement programs
  • You will develop good working relationships with customer groups and support an environment of teamwork
  • You will will be the primary quality assurance representative on multiple working teams and is empowered to make strategic Quality Assurance decisions
  • You will follow domestic and international GMP regulations, CGMPs, company policies, leadership capabilities, performance management, and department budget

Minimum Requirements/Qualifications:

  • BS in Engineering or Science and 3 or more years of project support experience with increasing responsibility in the areas of Quality Assurance
  • 5 or more years of industry experience in a pharmaceutical/biotech GMP environment
  • Knowledge of FDA and EMA regulations, ASTM E2500, ISPE BG5, process validation, and a working knowledge of statistical analysis and root cause analysis
  • Knowledge of plant utility and equipment systems from the QA support perspective
  • Experience with Quality systems impact assessments and oversight, integrating with existing systems
  • Proficiency with Microsoft applications including Word, Excel, Project, and Powerpoint; ability to learn additional software applications such as Trackwise and Veeva, LIMs experience

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.

Absent an approved religious or medical reason, all US field-based employees must be fully vaccinated for COVID-19, as a condition of employment.



In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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 - Alewife - BIO OPS

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Time Type

Full time

Posted: 2022-09-09 Expires: 2022-10-08
Sponsored by:
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Senior Quality Assurance Validation Specialist I

Shire Human Genetic Therapies, Inc.
Cambridge, MA 02139

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