Quality Control Technician II - Nights

BioSpace; Round Lake Beach (IL); On-site; USD 10,000 - 60,000; Full time

Job summary

An established industry player is seeking a dedicated Quality Control Technician II to ensure compliance and quality in manufacturing operations. This role involves performing Acceptable Quality Limit (AQL) sampling, managing samples, and supporting regulatory audits. The ideal candidate will have a strong foundation in Good Manufacturing Practices (GMP) and previous experience with quality assurance processes. Join a forward-thinking company that values quality and compliance, and contribute to the production of safe and effective products while working in a dynamic and supportive environment.

Qualifications

• 2+ years of related work experience in quality control.
• Knowledge of regulatory compliance and quality assurance processes.

Responsibilities

• Perform AQL sampling and assess quality risks in production.
• Initiate investigations for out-of-specification raw materials.

Skills

Good Manufacturing Practices (GMP)

Good Documentation Practices (GDP)

Quality Risk Assessment

Sample Management

Education

High School Diploma or GED

Associate's Degree

Tools

JDE

EBM

Systech

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

1. Perform Acceptable Quality Limit (AQL) sampling of finished product. Identify and assess quality risk in production operations daily.
2. Build Total Integrated Quality (TIQ)/ Quality on the Shop Floor (QOTSF) and review of checklists. Programs are part of manufacturing support and compliance enforcement.
3. Initiate JDE (inventory management system and preventive maintenance system) work orders if required to address issues.
4. 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.
5. Initiate investigations in the event of a failure about processes or Raw Material that is deemed to be out of specification.
6. Perform assessment with manufacturing, engineering, and maintenance to resolve potential issues on the floor and escalate.
7. Facilitate kitting operations for packaging – issue and return of preprinted materials physically and electronically.
8. Handle movement of materials/products physically and electronically for quarantine and reject areas.
9. Review Lead Manufacturing support activities including batch record documentation review. Perform approval of batch documentation and consult with manufacturing to address any required corrections.
10. Subject Matter Expert (SME) and provide training to other employees.
11. Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, and cGMP regulations.
12. Monitor product quality through the performance of required visual testing follow-ups.
13. 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.
14. Support regulatory audits.

What You Bring To Takeda

1. High School Diploma or GED with 2+ years of related work experience or Associates degree or higher and 1+ years related work experience.
2. Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
3. Experience 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.

Location: USA - IL - Round Lake - Drug Delivery

U.S. Hourly Wage Range: $18.85 - $29.62

The actual hourly wage offered may depend on qualifications, experience, skills, education, certifications, and location. U.S. employees may be eligible for incentives, benefits, and paid time off.

EEO Statement

Takeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, parental status, national origin, age, disability, or other protected characteristics.

Additional Details

Locations: USA - IL - Round Lake - Drug Delivery

Worker Type: Employee

Worker Sub-Type: Regular

Time Type: Full time

Job Exempt: No

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Quality Assurance

Industries

• Internet News

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