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Job Description

About the Role:

Responsible for providing Quality on the shop floor support for the IG/Albumin Purification, and/or Fill/Finish Operations. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules, guidelines and the company quality practices. 

How you will Contribute:

• Provides on-the-floor support to IG/Albumin Purification, and/or Fill/Finish in an ISO 8 environment.

• Will work with a cross-functional personnel to achieve defined quality goals in an efficient, accurate and timely manner.

• Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.

• Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques.  

• Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans.    

• Maintain Data integrity and ensure compliance with company SOPs, specifications, FDA, cGLP and cGMP regulations.

• Promote continuous improvements through participation (i.e. team leader/facilitator or major contributor) in the Quality Improvement Program.

• Oversees the aseptic techniques executed by manufacturing inside and outside of the filling isolator.

• Other duties, tasks or projects as assigned.

• Oversees the visual inspection and packaging operations executed by manufacturing

• Performs AQL sampling, sample reconciliation, and reject vial handling operations

• Must understand CFR requirements in regards to packaging, label controls, and visual inspection.

What you bring to Takeda:

• Typically requires bachelor's degree in chemistry, biological science, or other related technical field.

• Visual Inspection/Packaging: Highschool diploma required, Associates degree in business/scientific discipline preferred.  

• Minimum of three (3) years of experience in biopharmaceutical industry preferred.

• Visual Inspection/Packaging: Minimum of (1) year experience preferred 

• Strong interpersonal skills and great attention to detail are necessary.

• Must be a strong team player with good problem solving, and good verbal and written communication skills.

• Must be able to influence decisions based on regulatory knowledge.

• Must have the ability to manage people, encourage teamwork and drive decisions.

• Must be able to handle multiple projects concurrently.  

• Must have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices as appropriate.

• Must have adequate computer experience (knowledge of Microsoft Word, Excel and PowerPoint, TrackWise, Delta V)

• Must demonstrate excellent critical thinking skills and understanding of complex manufacturing processes and make risk based Quality Decisions on deviations based on knowledge of regulations and regulatory trends.  

• Visual Inspection ONLY:  • 20/20 eye sight (corrective lenses OK), no color blindness, attention to detail, and must be able to perform visual inspection of large parenteral vials. Hiring is dependent on the ability to pass visual exam and visual inspection qualification 

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.

#GMSGQ  #ZR1  #LI-MA1

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

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U.S. Base Salary Range:

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.

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Job Exempt