Laboratory Technician 4 (RD - RD - LABOR - TE10)

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Job description

The lab technician will work as a member of the QCE laboratory group. The purpose of this position is to help support QCE product release laboratory functions. The lab technician will be required to perform activities in the quality control laboratory supporting Manufacturing needs to ensure timely delivery of quality products to our customers.
This position is a Quality Control function in which the lab technician will work with the QCE team to help ensure timely release of intermediate and finished good products. This facility manufactures and releases products related to Diabetes and Urinalysis medical device product lines. Assurance of compliance with all regulatory standards and regulations as well as compliance with all corporate policies and guidelines is required.
Major Job Responsibilities

• Performs quantitative and qualitative analysis, such as sampling, testing, and measuring using specialized equipment.
• Completes the compiling, analyzing, and interpreting of results as well as preparation of product release reports
• Performs periodic equipment inspections and uploads documentation into applicable tracking system.
• Prepares measurement and test equipment (e.g. instrumentation and functionality tests).
• Performs a wide variety of assignments according to established procedures, including but not limited routine tests, data review and analysis, and solution preparations
• Ensures compliance of current procedures and processes and as needed reviews and updates documentation
• Provides inputs used for the purpose of control charting and trending of data collected through the release process
• Communicates issues encountered in the lab to initiate the investigation phase to the lab supervisor
• Performs urine screening and prepares solutions.
• Ensures general laboratory activities completed such as addressing inventory needs, putting samples under stability, and weekly/monthly 5S assignments.

Required Knowledge/Skills and Experience
• Ability to discern colors based on visual color product testing requirements
• Well-developed written and verbal communication skills
• Solid interpersonal and collaboration skills
• Ability to work in a fast paced environment, working well independently or in a team environment
• Proficient in Windows-based applications including Microsoft Access and Minitab Statistical Software
• Typically 1-2 years of successful experience in quality processes and knowledge of quality related processes and systems
• Knowledgeable of 21 CFR Part 820 regulations and ISO 13485 standard requirements
Education
Associates degree + 3 years practical and specialized experience, or specialized qualification needed.