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Job Description

About the role:

As a Quality Assurance Inspector II, you are responsible for inspection activities for all chemicals and components used in the manufacturing process. You will ensure raw materials meet specifications and reject those that fail to meet quality expectations.

How you will contribute:

• Perform sampling of chemicals in a classified room using appropriate gowning and safety measures.

• Perform routine cleaning of classified room used for chemical sampling.

• Conduct physical analysis on incoming chemicals as required per material’s specification.

• Responsible for the quarantine and/or destruction of nonconforming materials. 

• Responsible for inspection and release of production materials, components, and chemicals to manufacturing facility, including intermediate paste shipment verification, while ensuring adherence to SOPs and Material Specifications for accuracy and compliance.

• Responsible for sampling raw materials in an ISO classified environment, including preparation and shipment of samples to the required laboratories.

• Responsible for performing room cleaning and environmental monitoring in the ISO classified rooms.

• Perform tagging and untagging of non-conforming material in a timely manner, as well as inventory material in non-conforming areas; and coordinating non-conforming material returns to the supplier.

• Responsible for coordinating with third party bonded destroyers for the destruction of non-conforming material.

• Responsible for appropriate storage and disposal of retention and reference samples.

• Operate and proactively maintain laboratory and warehouse equipment through routine maintenance and/or calibrations. Ensure that equipment maintenance is properly documented in a timely manner.

• Maintain data integrity and ensure compliance with company SOP’s, Material Specifications, FDA, and cGMP regulations.

• Operate powered industrial equipment for material handling.

• Assist in internal self-inspections and external audits by collecting documents as assigned by management.

• Initiate Deviations and Lab Investigations, as needed, in a timely manner.

• Support execution of validations for laboratory and/or inspection equipment, laboratory methods and/or facility projects.

• May perform other duties as assigned by management.

• May provide training to others as assigned.

• Be able to support departmental / plant goals.

What you bring to Takeda:

• High school diploma or GED.  2+  years of related experience or AA (or equivalent) or higher with no prior experience required.    

• Familiar with cGMP and FDA requirements.

• Be able to have great attention to details is necessary.

• Ability to operate in a dynamic, high-paced, cross-functional environment.

• Be able to handle multiple tasks concurrently.

• Have strong organizational skills and the ability to follow-up on tasks.

• Have effective verbal and written communication skill.

• Be able to escalate issues affecting material’s quality in a timely manner.

• Have general computer knowledge.

• Have intermediate knowledge of laboratory and inspection tools, and warehouse equipment, as well as chemical handling.

• Have general knowledge of biotech manufacturing theories and processes.

• Have knowledge of Good Data and Documentation Practices (GDDP), current Good Manufacturing Practices (cGMP), and Environmental, Health and Safety (EHS) requirements preferred.

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.

• Must be able to lift, push, pull and carry up to 50 lbs.

• Must be able to operate warehouse machinery and equipment.

• In general, the position requires a combination of sedentary work, operating machinery, and equipment, and standing or walking to perform inspection and release

• Will work in office and warehouse environment.

• Will work with or around moving equipment and machinery.

• May be exposed to dust, gases, and fumes.

• Pace may be fast and job completion demands may be high.

• Must be able to work multiple shifts, including weekends.

• May be required to travel for business reasons, e.g. training and meetings. 5% travel.

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

For Location:

U.S. Hourly Wage Range:

The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. 

U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 

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