On-the-Floor 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

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.