Incoming Quality Technician III

Otsuka ICU Medical•Austin, TX

About The Position

The Incoming Quality Technician III (described in the posting as the Sr. Incoming Quality Technician) is responsible for data verification, technician training, project coordination, and leading or participating in departmental and plant projects that improve efficiency or support manufacturing. The technician serves as a primary or key subject matter expert during internal and external audits. The role helps ensure commodities are tested on time and according to applicable specifications for manufacturing use. This includes scheduling Incoming Quality technicians, reviewing sampling plans, performing commodity testing as needed, documenting investigations, and ensuring material is released only when it meets required specifications. The position involves inspecting raw materials visually, dimensionally, and functionally; maintaining accurate records and training materials; supporting equipment and software validation; and following cGMPs, SOPs, and plant policies. The work takes place in a laboratory and professional office environment and may involve potentially hazardous materials and use of personal protective equipment, including a respirator during sampling.

Requirements

At least 18 years of age.
High school diploma required.
Successful completion of a cognitive ability test.
Strong verbal and written communication skills, including the ability to communicate with Incoming Quality personnel, other departments, and management.
Ability to give direction to other laboratory technicians and promote teamwork.
Ability to interpret controlled drawings, specifications, and sampling plans.
Strong understanding of measurement techniques and excellent documentation skills.
Basic math skills, including arithmetic, significant figures, basic algebra, and working knowledge of the metric system.
Basic computer skills, including Microsoft Word, Excel, and Outlook.
Ability to troubleshoot and assist other technicians with equipment problems, solve routine problems logically, and handle unexpected assignments.
Ability to manage workload, prioritize issues, organize work, and handle multiple tasks simultaneously.
Mechanical aptitude and reasonable dexterity to operate testing devices.
Ability to wear appropriate PPE, including a respirator during sampling.
Ability to lift or manipulate up to 35 pounds with minimal assistance.

Nice To Haves

Five years of related laboratory experience preferred.
Two years of physical internal laboratory testing experience preferred.
Previous Incoming Quality experience preferred.

Responsibilities

Manage workload demands and schedule technician testing and material sampling to support timely production-material flow.
Document non-conforming material results through laboratory investigations and assist in generating Supplier Corrective Action Requests (SCARs).
Train Incoming Quality technicians as needed or directed.
Coordinate Incoming Quality records by ensuring area documentation is generated, filed, and stored according to department standards.
Verify testing data by reviewing completed documentation against applicable specifications and ensure testing is properly documented.
Ensure materials are released in accordance with required specifications.
Assist with validation of new instrumentation and software updates.
Perform measurements using laboratory tools such as calipers, rulers, and other instrumentation.
Follow cGMPs, SOPs, and plant policies and guidelines.
Work to resolve issues with supplier-provided documentation.
Maintain Incoming Quality training modules; act as a Qualified Fellow Employee (QFE); and periodically review and update training materials and SOPs.
Perform special testing (TSRs), special projects, and laboratory equipment operation.
Inspect raw materials visually, dimensionally, and functionally to confirm compliance with approved specifications.
Lead or participate in departmental and plant projects that improve efficiency or support manufacturing, and serve as a primary or key subject matter expert during internal and external audits.
Perform other duties as assigned or required.