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Job Description

About the role:

The primary responsibility is to serve the operations support group by ensuring compliance with procedures and regulatory requirements on the floor. You are responsible for investigations and escalation on the floor promptly to continue uninterrupted production. You are responsible for sample management (sterility, stability, etc.) and preparing shipments of those samples. Additional responsibilities include and are not limited to Triage, Deviation/CAPA initiation and investigation, raw material investigations, QOTSF, online batch documentation review, and serve as an SME for processes.

How you will contribute:

• Responsible for sample management (Sterility, stability, etc.) to appropriate facilities and responsible for the appropriate storage and disposal of retention samples.

• Complete investigations in the event of a failure on processes or Raw Material that is deemed to be out of specification.

• Triage potential issues on the floor. Initiate deviation and complete investigation.

• Revise documents to procedures, forms, and specifications.

• Manage the appropriate storage and disposal of retention and reserve samples.

• Identify and assess quality risk in production operations daily. QOTSF review of checklists and trending of observations for monthly quality council. QOTSF program management and JDE work order initiation.

• Perform Returned Goods, Product Hold, and Tagging and Untagging of non-conforming material promptly.

• Responsible for movement of materials/products physically and electronically for quarantine/reject areas and trained on PIT/forklift to move materials.

• Review and release pre-printed materials to manufacturing following cGMP procedures.

• Collect and submit rinse and bioburden samples to a laboratory.

• Oversee Manufacturing support activities, including batch record documentation review, approval of OSI PI Reports, scanner card management, label copy control and issuance, raw material release, in-process work order release, and retention sample management.

• Ensure pre-printed material label cage is maintained in a GMP state while following all EHS and 5S guidelines.

• Operate and maintain quality operations equipment. Ensure that equipment maintenance is documented promptly.

• Support execution of conformance protocols with appropriate training

• Be the Subject Matter Expert (SME) and provide training to other members.

• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, and cGMP regulations.

• Monitor product quality through the performance of required visual and functional testing.

• Contribute to a team setting within the quality operations and potentially with other work teams to increase efficiency, solve problems, produce cost savings, improve quality, and provide new product support

• Support regulatory audits.

What you bring to Takeda:

• High School Diploma or GED with 4+ years of related work experience or an Associates degree or higher and 2+ years related work experience.

• Good problem-solving skills.

• Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)

• Proficient in Microsoft Word, Excel, Outlook, and SharePoint.

• Work with JDE, EBM, TW workflows, Systech, and other LMS/DMS.

• Experience in pharmaceutical manufacturing of sterile drug and/or biologic solutions, preferred

• Some knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations, and application of cGMP/GDPs would be ideal

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:

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:

USA - IL - Round Lake - Drug Delivery

U.S. Hourly Wage Range:

$27.60 - $43.37

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.

Locations

USA - IL - Round Lake - Drug Delivery

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

No