Quality Assurance Specialist II

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About the role:

The Quality Assurance Specialist reports to the Quality Assurance Supervisor. In this position you will support the operation of a new, state-of-the-art plasma fractionation facility that will bring Shire additional capacity for testing, purification and fill finish for its biologic medications.

How you will contribute:

• Provide Quality oversight and manufacturing support as needed by Operations

• Perform timely review of batch record documents on the shop floor

• Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Shire quality practices

• Provide manufacturing floor coverage and attend daily cross-functional departmental meetings

• Identify nonconformance’s and participate in investigation and Corrective and Preventative Action (CAPA) activities

• Use Quality Systems to assess product impact or review data

• Author, review and/or approves written Standard Operating Procedures (SOPs) and submit procedural changes to meet requirements

Minimum Requirements/Qualifications:

• Bachelor’s degree in Engineering, Science or related field or equivalent. 2+ years of experience required

• Must have strong analytical and problem solving skills

• Must have knowledge of and understand application of Good Manufacturing Practices

• Experience with Quality Management Systems, EBM, and Digital Automation Systems

• Will spend a portion of time in clean room environment to provide oversight to manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines

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 paid time off for vacation, sick leave, and volunteering

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Professional development and 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. 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.

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

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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.