Takeda Pharmaceuticals Senior Quality Assurance Specialist in Lexington, Massachusetts
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
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
Professional training opportunities
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.
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 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.
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 - Lexington - BIO OPS
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