
Quality Document Management Specialist
Review and audit Batch History Records and test sheets for completeness, accuracy & compliance to GMP. Generate and review Device History Reports in SAP. Perform Result Recording and make Usage Decisions. Create Certificates of Analysis. Create Quality Notifications. Disposition material on Quality Notification. Maintain Batch History Record files. Gather information as requested for Regulatory Affairs registration requests. Adhere to GMP and ISO requirements. Follow all safety and housekeeping procedures. Maintain neat and orderly work area. Work additional time as required to meet business goals and requirements. Perform other duties as assigned to support business needs.
The ability to work in teams and independently with minimal supervision to obtain results as required.
Basic knowledge of the pertinent Quality Systems/Regulations (i.e. Good manufacturing Practices, ISO, FDA).
Capable of using enterprise systems such as SAP/ECC.
Time Management
MS Excel
MS Word
Documentation skills
Multitasking
Process Improvement
Verbal communication
Detail Oriented
written communication
According to JobzMall, the average salary range for a Quality Document Management Specialist in 2150 Commerce Dr, San Jose, CA 95131, USA is between $56,000 and $82,000. This range depends on several factors, such as experience, qualifications, certifications and the size of the company. Additionally, the cost of living in the area and the demand for the role can also affect salary range.
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The BD Life Sciences segment delivers innovative solutions from discovery to diagnosis, continually advancing science and clinical outcomes across infectious disease and cancer. Offerings include preanalytical solutions for sample management, immunology research solutions, including flow cytometry and multiomics tools, microbiology and molecular diagnostics, lab automation and informatics solutions, as well as differentiated reagents and assays.

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