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Job Description

Job Title: Sr. Quality Assurance Specialist

Location: Lexington, MA

About the role:

In this role, you will provide senior level support of QC, Warehouse, Cell Banking, and FEV quality systems of moderate complexity. This is a hybrid position, and you will report to the Quality Assurance Manager.

How you will contribute:

• Ensure that practices are consistent with quality and regulatory standards.


• Exercise judgment in selecting methods, techniques, and evaluation criteria for obtaining results


• Review documentation related to raw material, cell bank, UPB, and DS release. Perform disposition activities.


• Review equipment logbooks and records for compliance.


• Assure cGMP's and company procedures are followed and, if needed, procedures/policies are revised.


• Review and approve revised or created procedures (SOPs).


• Partner with other departments, to resolve issues. Develop and aid in development of solutions for problems


• Demonstrate high level of involvement in continuous improvement projects.


• Contribute to the development of new concepts, techniques, and standards.


• Provide support during regulatory agency site inspections.

• A minimum of a B.S. degree in science or engineering


• 5+ years experience in a cGMP QA or QC laboratory space


• Knowledge of FDA/EMEA regulations and root cause analysis

• 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


• Professional training opportunities


• Tuition reimbursement

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. 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.


• Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.


• Work in a cold, wet environment.


• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.


• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

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 to 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.

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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 - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time