Quality Control Technician II

Takeda Pharmaceutical Co.; Round Lake Beach (IL); On-site; USD 26,000 - 43,000; Full time

Job summary

Takeda Pharmaceutical Co. is seeking a Quality Control Technician II to ensure product quality and regulatory compliance on the manufacturing floor. You will perform AQL sampling, review batch documentation, and support QOTSF and deviations.

This role requires GMP/GDP knowledge, proficiency with MS Office, and ability to work with JDE and related systems. Shift includes evenings and weekends in a 6:00pm–6:30am schedule, and you will train others as SME.

Qualifications

• Holds GMP/GDP knowledge and experience in quality systems.
• Proficient with MS Word, Excel, Outlook, SharePoint.
• Able to learn and work with multiple QMS tools and document systems.

Responsibilities

• Performs Acceptable Quality Limit (AQL) sampling of finished product.
• Executes Quality on the Shop Floor (QOTSF) and checks checklists.
• Initiates JDE work orders for issues.
• Manages sample storage, disposal, and retention samples.
• Supports batch documentation review and approvals.
• Acts as SME and trains others as required.

Skills

Team player

Problem solving

Verbal communication

Written communication

GMP/GDP knowledge

MS Office (Word, Excel, Outlook, Share

Education

HS Diploma or GED with 2+ years

Associate’s degree or higher with 1+ years

Tools

JDE

EBM

TW workflows

Systech

Job description

Job Description

Join Takeda as a Quality Control Technician II, you will be responsible for ensuring compliance with procedures and regulatory requirements in the manufacturing facility. The incumbent is 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 triage 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.

About the role:

Quality Control Technician II is focused on ensuring the quality of processes and product outputs. This includes defining and specifying activities, processes, and standards to meet quality requirements, auditing and monitoring processes, and ensuring product integrity. This role contributes to Takeda's mission by maintaining high standards of quality and compliance.

How you will contribute:

• Performs Acceptable Quality Limit (AQL) sampling of finished product. Identifies and assesses quality risk in production operations daily.
• Executes Quality on the Shop Floor (QOTSF) and reviews checklists. Programs are part of manufacturing support and compliance enforcement.
• Initiation of JDE (inventory management system and preventive maintenance system) work orders if required to address issues in a timely manner.
• Performs sample management (Sterility, stability, etc.) to appropriate facilities and is responsible for the appropriate storage and disposal of retention samples. Performs triage with manufacturing, engineering, and maintenance to resolve potential issues on the floor and elevate if needed.
• Facilitates kitting operations for packaging – issue and return of preprinted materials physically and electronically.
• Handles movement of materials/products physically and electronically for quarantine and reject areas.
• Review Lead Manufacturing support activities, including batch record documentation review. Perform review and approval of batch documentation and consult with manufacturing to address any required corrections.
• Subject Matter Expert (SME) and provides training to other employees as required.
• 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.
• Actively contributes to a team setting within quality operations and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.

• Support regulatory audits as required.

What you bring to Takeda:

• HS Diploma or GED with 2+ years, Associate’s degree or higher with 1+ years of relevant industry experience
• Team player with good problem-solving and good verbal and written communication skills.
• Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Proficient in Microsoft Word, Excel, Outlook, and SharePoint.
• Able to learn and work with JDE, EBM, TW workflows, Systech, and other Learning Management and Document Management systems.
• Ability to work independently while contributing effectively in a multidisciplinary team environment.

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:

• In general, the position requires a combination of sedentary work and walking around, observing the conditions of the facility.
• Must be able to lift, push, pull, and carry up to 50 lbs. without material handling equipment, and push or pull pallets of material with material handling equipment. Must be able to stand and/or walk for an extended period over an 8–12-hour shift between rooms and across the site.
• May require bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks
• Repetitive motions with hands, wrists, turning head, bending at knees, and waist.
• 20/20 near and distance vision (Applies to roles performing visual inspection only) with or without glasses and/or contacts.
• May not be colorblind (Applies to roles performing visual inspection only).
• Indoor working conditions.
• Will work around moving equipment and machinery.
• 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. Some Clean Room and/or cool/hot storage conditions.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary. The shift is 6:00pm-6:30am, 2-2-3.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• May be exposed to and must not be allergic to cephalosporin.

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.

For Location:

USA - IL - Round Lake - Drug Delivery

U.S. Hourly Wage Range:

$19.81 - $31.10

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.

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