Quality Assurance Associate

Tosoh Bioscience, Inc., based in South San Francisco, CA is a U.S. subsidiary of Tosoh Corporation's Bioscience Division, headquartered in Tokyo, Japan. Established in the United States in 1989, Tosoh Bioscience has become known throughout the Americas for providing sophisticated diagnostic systems to doctor's offices, hospitals and reference laboratories. Tosoh remains at the forefront with a world class network of research facilities, scientists, engineers and customer support specialists.

Summary

Under direction of the Manager of Documentation the Quality Assurance Associate is responsible for assisting in the implementation of functions of Quality Assurance to meet customer and corporate requirements in support of all Tosoh processes and products.

Major Duties and Responsibilities

• Follow Work Instructions associated with the Quality System.

• Training: Create and administer SmartSolve Training; manage training files; monitor training matrices and communicate to management.

• Document Controls: Assist with coordination and management of all Quality documents within Tosoh Bioscience, Inc.

• Document Management System (SmartSolve): Assist with all SmartSolve functions for Documentation, Change, and Training

• Internal audits: Assist as needed for audits, audit documentation.

• External audits, ISO, FDA, other regulatory bodies: Assist as needed for audits, audit documentation.

• Trending Analysis, including report for Management Review and Trend Review Board

• CAPAs and Nonconformances: Assist with CAPAs and NCs, monitoring for completion, sending reminder notifications, as needed.

Education

• Degree in Medical Technology, Chemistry or Biology

Skills and Qualifications

• Experience with FDA Regulations/Quality System Management

• Proficient in general computer and documentation skills, including Microsoft Office Applications (Word, Excel, PowerPoint).

• Good communication skills and understanding of business-related aspects with regards to confidentiality of corporate affairs.

• High attention to detail, organized work habits and the ability to multi-task.

• Ability to work independently with minimal supervision.

• Ability to travel on a limited basis as the job requires.

• Knowledge of Tosoh instrumentation a plus, but not essential.

Physical Requirements

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required to be successful. Additional duties may be assigned in the future as required. Reasonable accommodations may be made for those individuals with disabilities in order to perform the essential functions.

Tosoh Bioscience, Inc. is an Equal Opportunity Employer M/F/Disabled/Veterans