Quality Control Technician II - Nights

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

Job summary

An established industry player in pharmaceutical manufacturing is seeking a Quality Control Technician II for night shifts. This role is pivotal in ensuring compliance with regulatory standards and maintaining product quality. You will engage in AQL sampling, manage raw material investigations, and collaborate with various teams to uphold quality operations. If you have a passion for quality assurance and a keen eye for detail, this opportunity offers a chance to make a significant impact in a dynamic environment. Join a team dedicated to excellence and innovation in drug delivery.

Benefits

Health Insurance

401(k)

Paid Time Off

Qualifications

• 2+ years of experience in quality control or an Associate degree with 1+ years.
• Knowledge of GMP and GDP essential for compliance.

Responsibilities

• Perform AQL sampling and assess quality risks in production.
• Collaborate with teams to resolve potential quality issues.

Skills

GMP Knowledge

Quality Control

Investigative Skills

Sample Management

Education

High School Diploma or GED

Associate Degree

Tools

JDE

EBM

Systech

Job description

Join to apply for the Quality Control Technician II - Nights role at Takeda.

This range is provided by Takeda. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$18.85/hr - $29.62/hr

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, including presence on the floor and performing Acceptable Quality Limit (AQL) sampling of finished product. Additional responsibilities include assessment of 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 risks in production daily.
2. Build Total Integrated Quality (TIQ)/ Quality on the Shop Floor (QOTSF) and review checklists. These programs support manufacturing and compliance.
3. Initiate JDE (inventory management system and preventive maintenance system) work orders as needed.
4. Perform sample management (sterility, stability) and ensure proper storage and disposal of retention samples. Handle raw material samples in an ISO environment, including preparation and shipment to laboratories.
5. Initiate investigations for processes or raw materials out of specification.
6. Collaborate with manufacturing, engineering, and maintenance to resolve potential issues and escalate when necessary.
7. Facilitate kitting operations for packaging, including issuing and returning preprinted materials both physically and electronically.
8. Manage movement of materials/products for quarantine and reject areas.
9. Review batch record documentation, approve batches, and consult with manufacturing for corrections.
10. Serve as Subject Matter Expert (SME) and provide training to other employees.
11. Maintain data integrity and ensure compliance with SOPs, FDA, and cGMP regulations.
12. Monitor product quality through visual testing follow-ups.
13. Contribute to team efforts within quality operations and other teams to improve efficiency, quality, and support new products.
14. Support regulatory audits.

Qualifications

• High School Diploma or GED with 2+ years of related experience, or an Associate degree or higher with 1+ years of related experience.
• Knowledge of GMP and GDP.
• Experience with JDE, EBM, TW workflows, Systech, and document management systems.

Additional Considerations

• Work involves a combination of sedentary tasks and walking around the facility.
• Physical requirements include carrying up to 10 lbs, lifting up to 10 lbs, pushing/pulling up to 20 lbs with equipment assistance.
• Extended standing and walking during shifts.
• Repetitive hand and wrist motions, bending, reaching, and squatting.
• Indoor working conditions, possibly in controlled environments requiring safety gear.
• Potential work with allergens such as cephalosporin.
• Visual acuity of 20/20 and non-colorblindness required for visual inspections.

Compensation and Benefits

Takeda offers equitable pay and transparency, with benefits including health insurance, 401(k), paid time off, and more, depending on location and role.

Location

USA - IL - Round Lake - Drug Delivery

Employment Details

• Type: Full-time
• Exempt: No
• Seniority level: Entry level
• Job function: Quality Assurance
• Industry: Pharmaceutical Manufacturing