Quality Assurance Technician

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 doctors' 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 the direction of the Supervisor of Document Control, the Quality Assurance Technician is responsible for supporting and maintaining Quality Assurance systems to ensure compliance with customer requirements, regulatory standards, and corporate quality objectives across all Tosoh processes and products. This position plays an important role in maintaining the effectiveness of the Quality Management System (QMS) through quality monitoring, documentation management, compliance activities, and support of continuous improvement efforts.

The Quality Systems Technician is responsible for inspecting materials, performing laboratory testing, reviewing and documenting quality data, communicating findings, and maintaining quality records. This position assists with ensuring adherence to company policies, quality standards, and applicable regulations while supporting quality system processes and initiatives. The role works closely with Manufacturing, Regulatory Affairs, Supply Chain, and other cross- functional teams to address quality issues, support audits, maintain documentation, and promote operational efficiency. The position requires strong attention to detail, organizational and time-management skills, analytical thinking, and the ability to work both independently and collaboratively in a team environment.

Reporting Relationships

The Quality Assurance Technician, reports to the Supervisor of Document Control.

Major Duties and Responsibilities

• Ensure compliance with company policies, safety regulations, and GMP (Good Manufacturing Practice) industry standards.
• Execute and coordinate a variety of laboratory testing.
• Operating laboratory equipment such as, but not limited to, balances, pH meters, conductivity meters, UV spectrometers, etc. and perform routine laboratory department maintenance to keep area clean and orderly.
• Manage laboratory supplies and equipment inventory.
• Execute quality inspection of products, labeling and other materials for release.
• Perform line clearance, visual Inspection, and other quality checks of in-process and post-production materials.
• Provide support and participate in the execution of distribution of notification letters to customers.
• Quality Systems Support: Assist with the management of quality system activities, including, but not limited, to CAPAs, nonconformances, change controls, and other quality records, by supporting investigations, root cause analysis, gap assessments, tracking progress, monitoring completion, and sending follow-up reminders as needed.
• Execute data entry and maintenance of records within quality management systems (QMS), databases, and other electronic filing systems.
• Support the creation and formatting of controlled documents (i.e. standard operating procedures, work instructions, etc).
• Review quality records for completeness, accuracy, and GDP compliance
• Scan, file, and archive GMP records according to internal procedures and regulatory requirements.
• Ensure accurate receipt, logging, distribution, tracking and archival of quality documentation.
• Coordinate audit readiness activities and prepare requested documentation for FDA, ISO, customer, and internal audits.
• Communicate defects, non-conformities, and other quality concerns effectively to management.
• Generate reports for tending analysis
• Collaborate with cross-functional teams to resolve quality issues.
• Perform Quality System projects, process improvements, data integrity initiatives, and implementation of new quality procedures as needed or on an ongoing basis to support other job duties as required.
   

Education

• High school diploma or equivalent required. Preferred Associate's or Bachelor's degree in biology, chemistry, biochemistry, bioengineering or other technical related degree.
• Equivalent combinations of education, training, and relevant experience will be considered. Candidates with demonstrated experience in the medical device industry, FDA-regulated environments, or related regulated manufacturing industries may qualify in lieu of a degree.
   

Skills and Qualifications

• Proficient in Adobe and Microsoft Office applications, including Word, Excel, Outlook, and Teams.
• Working knowledge of FDA regulations, ISO 13485, GMP/cGMP, GDP, GLP, and quality system requirements is preferred, but not required.
• Experience with electronic QMS/document management systems.
• Minimum of 1-2 years experience in a cGMP environment or willingness to learn.
• Effective written and verbal communication skills.
• Problem-solving and critical-thinking abilities.
• Ability to follow established procedures and work instructions.
• Ability to work independently with minimal supervision.
• Adaptability and willingness to learn new systems and processes.
• Strong attention to detail and organizational skills.
• Strong data entry and recordkeeping skills with a high degree of accuracy.
• Ability to manage multiple tasks and prioritize work in a fast-paced environment.
• Ability to handle confidential and sensitive information appropriately.
• Knowledge of Tosoh instrumentation a plus, but not essential.

Working Conditions

• Position operates in a combination of office, laboratory, warehouse, and manufacturing environments.
• Exposure to regulated GMP manufacturing and laboratory environments requiring adherence to established safety, quality, and hygiene procedures.
• May require occasional interaction with cleaning chemicals, laboratory reagents, and manufacturing materials while following applicable safety protocols.

Physical Requirements

The physical demands of this job are representative of those that must be met by an employee to successfully perform the essential functions of this job. 

• Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. 
• Ability to speak clearly over the telephone so that others can understand. 
• Ability to visit and move around at customer sites. 
• Ability to travel domestically and internationally, by both auto and air, up to 35% of the work year.

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