Quality Control Technician II
Round Lake Beach, Illinois
Business Area Overview
At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma Collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.
Working at Takeda
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Recognized for our culture and way of working, we’re one of only 11 companies to receive Top Global Employer® status for 2022.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
Quality Control Technician IIJob ID R0073917 Date posted Aug. 18, 2022 Location Round Lake Beach, Illinois
About the role:
The Quality Control Technician is in the Quality Operations organization at the Takeda Round Lake aseptic pharmaceutical manufacturing facility. The employee’s primary responsibility will be ensuring compliance with procedures and regulatory requirements on the manufacturing floor. The employee’s secondary responsibility will be providing Quality oversight of daily manufacturing operations.
How you will contribute:
- Quality Operations: Monitor product quality through the performance of required visual and functional testing. Promote continuous improvement through participation in Quality Improvement programs (i.e., Total integrated quality checklists, Quality on the Floor checklists, etc.).
- Quality Systems: Follows Standard Operating Procedures to execute required work. Actively collaborates with cross-functional personnel to continually improve Quality System processes.
- Deviations and CAPA: Escalates potential deviations to relevant management.
- Quality Leadership: Supports Quality project teams. Review manufacturing processes for cGMP compliance on the floor.
- Maintain department equipment and inventory levels for controlled materials.
- Respond to issues which arise on the manufacturing lines
- Assist with control of in-process sampling activities and ensure timely delivery of samples to appropriate QC test laboratories.
- Inspect and release of production materials, components, and chemicals to manufacturing facility, including Intermediate bulk shipment verification.
- Sample Raw Materials in an ISO Classified environment, including preparation and shipment of samples to the required laboratories.
- Review and release pre-printed materials to manufacturing following cGMP procedures.
- Collect and submit rinse and bioburden samples to laboratory.
- Prepare stability sample shipments and perform visual inspection testing, if required.
- Perform material/component release and in-process work order release using JDEdwards (C3ME) system.
- Perform review and approval of batch documentation and consult with manufacturing to address any required corrections.
- Perform routine audits of the manufacturing areas to assess current safety and compliance risks.
What you bring to Takeda:
- Ability to handle multiple tasks concurrently, and in a timely fashion
- Must communicate effectively (verbal and written) with supervisors and peers
- Ability to understand complex problems and anticipate consequences of actions/decisions made
- Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
- High School Diploma or GED with 2+ years of related work experience or Associates degree or higher and 1+ year related work experience.
- Experience in pharmaceutical manufacturing of sterile drug and/or biologic solutions, preferred
- Proficiency with typing, word processing and use of Microsoft Office programs (Word, Excel).
- Some knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations, application of cGMP/GDPs
- In general, the position requires a combination of sedentary work and walking around observing conditions of the facility.
- Must be able to carry up to 20lbs, lift up to 20lbs, push/pull up to 20lbs (with assistance of material handling equipment).
- Must be able to work nights, weekends, and holidays to support manufacturing when needed.
- 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 vision with or without corrective lenses at distance and up close
- May not be colorblind
What Takeda can offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs and company match of charitable contributions
- Family Planning Support
- Professional training and development opportunities
- Tuition reimbursement
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:
- Indoor working conditions
- Will work around moving equipment and machinery
- May be required to work in controlled environments requiring special safety gear or gowning; will be required to 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.
- May be required to work in confined spaces/areas.
- Some Clean Room and/or cool/hot storage conditions.
- May be exposed to and must not be allergic to cephalosporin
- Must be able to work 2-2-3 shift, including weekends and holidays, to support a 24/7 manufacturing operation as needed.
- Must be able to work non-traditional work hours, including weekends and holidays, as needed.
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.
This posting excludes Colorado applicants.
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.
LocationsUSA - IL - Round Lake - Drug Delivery
Time TypeFull time
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