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Job Description

Job Title: Senior QA Operations Specialist

Location: Lexington (USA)

About the role:

In this role, you are responsible for routine management and coordination of GMP compliance systems and policies for cGMP compliant facilities. This is a hybrid role, and you will to the Head of Quality Assurance.

How you will contribute:

• You will review and approve Quality Systems which include deviations and CAPA and supporting disposition.
• You will collaborate with multiple departments to ensure appropriate RCA and CAPAs have been identified.
• You will monitor policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction.
• You will demonstrate high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained.
• You will examine programs to create efficiencies in practices and optimal utilization of staff.
• You will review production records for compliance.
• You will assure cGMP’s and company procedures are followed and, if needed, procedures/policies are revised.
• You are accountable for meeting functional area objectives as they relate to departmental and company-wide goals.
• You are responsible for adhering to GMP regulations, cGMP’s, company policies, and leadership capabilities.

What you Bring to Takeda

• B.S. degree in science or engineering
• 5+ years experience interacting in QA functions in a cGMP environment
• 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
• 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 and development opportunities
• Tuition reimbursement

Important Considerations:

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. In this role, 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/or 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 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 posting excludes Colorado applicants.

#GMSGQ

#ZR1

#LI-Hybrid

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