Hybrid Technician I, Incoming Quality at Otsuka ICU Medical

Position Summary 

The IQ Technician performs acceptance sampling and inspection of commodities per applicable specifications for use in final product manufacturing.  The IQ Technician uses a variety of technical equipment and measuring instruments to ensure acceptability of incoming materials.

Essential Duties & Responsibilities

• Execute sampling of commodities and active pharmaceutical ingredients consistent with approved sampling plans. 
• Establish and maintain proper documentation of test results, which includes proper entry of data on IQ worksheets, batch records, miscellaneous test forms and quality histories.  Complete sampling plan documentation and peer review. 
• Ensure proper material identification, segregation, and storage during testing and storage of in-process materials and retention samples
• Perform inspection of raw materials visually, dimensionally, functionally for conformance to approved specifications. Inspect, test (physical) and evaluate incoming commodities and printed materials against specifications (commodity specs, masters, summaries) and applicable Standard Operating Procedures (SOPs).   
• Operate specialized measurement equipment (Laser displacement, optical comparator, melt flow index, Nikon Measurescope, FTIR, Instron, Beta Laser Mike, etc.) during quality inspection of incoming commodities. 
• Adhere to cGMP's, SOP's and plant policies/procedures.
• Participate in laboratory investigations as required.
• Identify and help resolve issues with documentation provided by suppliers.
• Perform other duties as assigned or required.

Knowledge & Skills

• [Must have working knowledge of the Imperial and metric system and how to convert fractions.
• Must have good basic math skills (add; subtract, multiply, divide significant figures, basic algebra).
• Ability to interpret controlled drawings and specifications. 
• Work well with others to solve problems and handle unexpected assignments.
• Minor trouble shooting of equipment problems.
• Communicate effectively with personnel from other departments and various levels of management.
• Manage workload demands to ensure the timely flow of production material.
• Must be able to manage workload demands, handle identified issues, and prioritize accordingly. 
• Must be able to organize their work and handle multiple tasks simultaneously. 
• Use logic to solve routine problems. 
• Mechanical aptitude and reasonable dexterity is required to operate various testing devices. 
• Strong understanding of measurement techniques and excellent documentation skills.   
• Successful completion of a cognitive ability test required

Minimum Qualifications, Education & Experience 

• Must be at least 18 years of age
• High school diploma or equivalent required.
• Requires 0-1 year of experience. Previous quality laboratory experience and/or pharmaceutical manufacturing experience is preferred.

Work Environment

• This position performs inspection of raw materials visually, dimensionally, and functionally to ensure compliance to approved specifications. Failure to meet specifications may delay manufacturing of product.
• The IQ Technician must be able to read and interpret drawings, commodity/drug specifications, sampling plans, and technical specifications.
• Physical lab environment involving working with some potentially hazardous materials. 
• Must be able to wear appropriate PPE. 
• Will need to be able to wear a respirator and personal protective equipment during sampling

Typically requires travel less than 5% of the time

Company