About the Role:
Provide 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 our quality practices.
How you will Contribute:
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Provide on-the-floor support to IG/Albumin Purification, and/or Fill/Finish in an ISO 8 environment.
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Will work with a cross-functional personnel to achieve defined quality goals in an efficient, accurate and timely manner.
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Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.
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Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques.
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Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans.
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Maintain Data integrity and ensure compliance with company SOPs, specifications, FDA, cGLP and cGMP regulations.
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Promote continuous improvements through participation (i.e. team leader/facilitator or major contributor) in the Quality Improvement Program.
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Oversee the aseptic techniques performed by manufacturing inside and outside of the filling isolator.
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Other responsibilities, tasks or projects as assigned.
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Oversee the visual inspection and packaging operations executed by manufacturing
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Perform AQL sampling, sample reconciliation, and reject vial handling operations
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Must understand CFR requirements regarding packaging, label controls, and visual inspection.
What you bring to Takeda:
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Typically requires bachelor’s degree in chemistry, biological science, or other related technical field.
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Visual Inspection/Packaging: Highschool diploma required, Associates degree in business/scientific discipline preferred.
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Minimum of three (3) years of experience in biopharmaceutical industry preferred.
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Visual Inspection/Packaging: Minimum of (1) year experience preferred
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Must be a strong team player with good problem solving skills
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Must be able to drive decisions based on regulatory knowledge.
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Must have the ability to manage people, encourage teamwork and drive decisions.
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Must have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices as appropriate.
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Must have adequate computer experience (knowledge of Microsoft Word, Excel and PowerPoint, TrackWise, Delta V)
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Must demonstrate an excellent understanding of complex manufacturing processes and make risk based Quality Decisions on deviations based on knowledge of regulations and regulatory trends.
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Visual Inspection ONLY: • 20/20 eye sight (corrective lenses OK), no color blindness, attention to detail, and will 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:
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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.
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Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
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Work in a cold, wet environment.
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Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
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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.
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