Job Description

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Job Description

About the role:

The primary responsibility is to ensure compliance with procedures and regulatory requirements in the manufacturing facility. You are responsible for quality support and oversight of manufacturing operations, which includes presence on the floor and for performing Acceptable Quality Limit (AQL) sampling of finished product. Additional responsibilities include assessment for potential issues on the floor, raw material investigations, Quality on the Shop Floor (QOTSF), online batch documentation review, sample management, kitting of batches, and raw materials release.

How you will contribute:

• Perform Acceptable Quality Limit (AQL) sampling of finished product. Identify and assess quality risk in production operations daily.
• Build Total Integrated Quality (TIQ)/ Quality on the Shop Floor (QOTSF) and review of checklists. Programs are part of manufacturing support and compliance enforcement.
• Initiate JDE (inventory management system and preventive maintenance system) work orders if required to address issues in.
• Perform sample management (Sterility, stability) to appropriate facilities and responsible for appropriate storage and disposal of retention samples. Samples Raw Materials in an ISO Classified environment, including preparation and shipment of samples to the required laboratories.
• Initiate investigations in the event of a failure about processes or Raw Material that is deemed to be out of specification.
• Perform assessment with manufacturing, engineering, and maintenance to resolve potential issues on the floor and escalate.
• Facilitate kitting operations for packaging – issue and return of preprinted materials physically and electronically.
• Handle movement of materials/products physically and electronically for quarantine and reject areas.
• Review Lead Manufacturing support activities including batch record documentation review. Perform approval of batch documentation and consult with manufacturing to address any required corrections.
• Subject Matter Expert (SME) and provides training to other employees.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, and cGMP regulations.
• Monitor product quality through the performance of required visual testing follow ups.
• Contribute to a team setting within quality operations and potentially with other work teams to increase efficiency, produce cost savings, improve quality, and provide new product support.
• Support regulatory audits.

What you bring to Takeda:

• High School Diploma or GED with 2+ years of related work experience or Associates degree or higher and 1+ years related work experience.
• Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Work with JDE, EBM, TW workflows, Systech and other Learning Management and Document Management systems.

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. You may:

• In general, your work will be a combination of sedentary work and walking around observing conditions of the facility.
• Can carry up to 10lbs, lift up to 10lbs, push/pull up to 20lbs (with assistance of material handling equipment).
• Will stand and walk for an extended period over an 8–12-hour shift between rooms and across the site.
• May require bending, twisting, reaching overhead, and squatting motions to perform certain tasks
• Repetitive motions with hands, wrists, turning head, bending at knees and waist.
• Indoor working conditions.
• Will work around moving equipment and machinery.
• May work in controlled environments requiring special safety gear or gowning; will follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body. No make-up, jewelry, nail polish, or artificial fingernails may be worn in the manufacturing environment.
• Some Clean Room and cool/hot storage conditions.
• May work with and must not be allergic to cephalosporin.
• 20/20 near and distance vision (Applies to roles performing visual inspection only) with or without glasses and contacts.
• Must not be colorblind (Applies to roles performing visual inspection only).

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.  

For Location:

USA - IL - Round Lake - Drug Delivery

U.S. Hourly Wage Range:

$18.85 - $29.62

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 e mployee s may be eligible for s hort - t erm 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.

Locations

USA - IL - Round Lake - Drug Delivery

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

No

Job Tags

Hourly pay, Minimum wage, Holiday work, Full time, Temporary work, Work experience placement, Local area, Immediate start, Shift work, Night shift,

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