Quality Control Technician II

Takeda•Round Lake, IL

1d•$20 - $31•Onsite

About The Position

The Quality Control Technician II ensures compliance with procedures and regulatory requirements in Takeda’s manufacturing facility, providing quality support and oversight of manufacturing operations. The role includes a presence on the manufacturing floor and Acceptable Quality Limit (AQL) sampling of finished product. It also supports quality processes and product integrity by defining and following quality activities, monitoring processes, and ensuring product outputs meet applicable standards. The technician supports manufacturing through floor triage, raw material investigations, Quality on the Shop Floor (QOTSF), online batch documentation review, sample management, batch kitting, and raw material release. The role maintains data integrity and compliance with company procedures, specifications, FDA requirements, and cGMP regulations; provides training as a subject matter expert; and supports regulatory audits as needed.

Requirements

High school diploma or GED with at least 2 years of relevant industry experience, or an associate degree or higher with at least 1 year of relevant industry experience.
Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) knowledge.
Proficiency in Microsoft Word, Excel, Outlook, and SharePoint.
Ability to learn and work with JDE, EBM, TW workflows, Systech, and other learning management and document management systems.
Good problem-solving, verbal communication, and written communication skills.
Ability to work independently while contributing effectively in a multidisciplinary team environment.
Ability to lift, push, pull, and carry up to 50 pounds without material-handling equipment, and to push or pull pallets using material-handling equipment.
Ability to stand and/or walk for extended periods during an 8–12-hour shift, and to perform bending, twisting, overhead reaching, squatting, and repetitive motions.
For roles performing visual inspection: 20/20 near and distance vision, with or without glasses or contacts, and must not be colorblind.
Ability to work in controlled manufacturing environments requiring gowning and protective clothing, potentially including hearing protection.
Must remove makeup, jewelry, contact lenses, nail polish, and artificial fingernails in the manufacturing environment.
Ability to work in cold and wet environments and in clean-room or cool/hot storage conditions.
Ability to work around chemicals such as alcohol, acids, buffers, and Celite, which may require respiratory protection.
Must not be allergic to cephalosporin.

Responsibilities

Perform Acceptable Quality Limit (AQL) sampling of finished product and identify and assess quality risks in production operations.
Execute Quality on the Shop Floor (QOTSF) activities and review associated checklists.
Initiate JDE work orders when required to address issues in a timely manner.
Manage samples, including sterility and stability samples, ensuring appropriate delivery, storage, and disposal of retention samples.
Triage potential floor issues with manufacturing, engineering, and maintenance, and escalate issues when needed.
Facilitate packaging kitting operations, including physical and electronic issuing and return of preprinted materials.
Move materials and products physically and electronically to quarantine and reject areas.
Support lead manufacturing activities, review batch record documentation, and review and approve batch documentation; consult manufacturing on required corrections.
Serve as a subject matter expert and train other employees as required.
Maintain data integrity and comply with company SOPs, specifications, FDA requirements, and cGMP regulations.
Monitor product quality by performing required visual testing follow-ups.
Contribute to quality operations and cross-functional teams to improve efficiency and quality, solve problems, generate cost savings, and support new products.
Support regulatory audits as required.