Quality Control Technician II

USA - 3390 Baxalta U.S., Inc.; Round Lake (IL); On-site; USD 41,000 - 65,000; Full time

Job summary

Takeda in Round Lake, IL is hiring a Quality Control Technician II to support manufacturing quality and regulatory compliance. The role focuses on AQL sampling of finished product, QOTSF, batch documentation review, and issue resolution on the shop floor, ensuring product integrity and timely material release.

You will train colleagues, maintain data integrity, and support GMP/GDP practices while collaborating with cross-functional teams in a fast-paced, controlled manufacturing environment.

Qualifications

• HS Diploma or GED with 2+ years experience; Associate degree or higher with 1+ years experience.
• Proficient with GMP and GDP; able to learn JDE, EBM, TW workflows, Systech, and LMS/DMS systems.
• Strong communication and teamwork; able to work independently in a multidisciplinary environment.

Responsibilities

• Performs AQL sampling of finished product.
• Identifies and assesses quality risk in production daily.
• Executes QOTSF and reviews checklists.
• Initiates work orders in JDE to address issues promptly.
• Performs sample management and proper storage/disposal of retention samples.
• Reviews batch documentation and supports manufacturing to correct discrepancies.
• Trains others as SME and ensures data integrity per SOPs and FDA/cGMP.

Skills

GMP knowledge

GDP knowledge

Problem solving

Verbal & written communication

Team collaboration

Education

HS Diploma or GED

Associate degree or higher

Tools

JDE

EBM

TW workflows

Systech

SharePoint / LMS/DMS familiarity

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 escalates 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.

Takeda Compensation and Benefits Summary

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. For information about our benefits, please

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 Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda‑ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer. For applicants of U.S and Puerto Rico positions:

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