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Hyve Solutions in Fremont, CA is seeking a QA-focused role responsible for inspecting and testing in-process materials and finished products to ensure compliance with GLP, GMP, ISO, and internal standards. The position involves documenting procedures, analyzing inspection data, and recommending corrective actions to maintain quality across products.
Responsibilities include conducting QA inspections, developing testing methods, and aligning with Six Sigma initiatives when applicable.
Evaluates and implements protocols and methods to inspect and test in-process raw materials and finished products and ensure that they are in compliance with internal and external safety, quality and regulatory standards requirements for distribution. Performs analysis and identifies trends in the inspection of finished products, in-process materials and bulk raw materials, and recommends corrective actions when necessary. Develops processes and tests to determine that appropriate quality control analysis is being performed. Prepares documentation for inspection/testing procedures. Evaluates and analyzes the efforts in organizing, documenting and interpreting inspection support documents and records. May assure compliance to in-house and/or external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma).
For the Medical Devices Industry, may specialize in the function specifically as it applies to BLAs (biological licensing agreements).
Pay is $26.50 depending on experience.