QA Associate

Overview

Job Title:

QA Associate I.

Reports to:

Director, Quality Assurance. FLSA Class:
Non-exempt.

Learn more about our company and how we support you:
Takara Bio USA (TBUSA) empowers life science discovery. We bring innovation and inspiration to every scientist—promoting discoveries that improve health and the environment. We hold values that all employees and prospective candidates should demonstrate:
Innovation, Teamwork, Integrity, Respect, Growth, Diversity and Quality. We value helping employees develop their skills and you will be part of this journey!

The QA Associate I role is responsible for providing general support to the Quality department. This role helps to maintain the quality management system under close supervision and guidance.

QA Associate I is responsible for carrying out general quality functions or activities, as assigned. The QA Associate I receives guidance on workload prioritization from the team lead or management but is ultimately responsible for organizing and executing their projects and daily standard workload in a manner which meets the schedules of the operational teams whom they support.

In this on-site role located in San Jose, CA, the QA Associate I will perform tasks in support of the quality management system such as implementing quality assurance procedures and work instructions, supporting company preventive maintenance and calibration program, performing data entry of part numbers and BOM information into the ERP system, supporting database maintenance, generating and reviewing product documentation such as product labels, SDS and COAs, supporting receiving inspections, customer requests and continuous quality improvement activities.

• Responsible for implementation of routine and non-routine quality assurance projects.
• Participates in quality and process improvement projects.
• Provides help in troubleshooting document control issues.
• Maintains product, quality, and/or regulatory information in relevant databases.
• Creates reports on quality-related performance indicators.
• Works with the SDS team in generating Safety Data Sheets for products.
• Limited responsibility for the review, release, and distribution of product technical documentation and for the implementation of documentation changes due to Engineering Change Notices.
• Interacts with various groups, shares information, and participates in team activities.
• Performs duties in support of functional operations and customer requirements; supports an environment of changing priorities.
• Makes informed decisions on simple to moderate issues in collaboration with key stakeholders and in alignment with company policies.
• Has an intimate knowledge of all safety requirements of the job and may be required to train others.
• This position does not have supervisory responsibilities.

• BA/BS degree in a scientific discipline or engineering (required).
• Minimum 0-2 years of experience in a Quality Assurance role for a life sciences, medical devices, or biotech industry.
• Experience with ISO 9001/13485 and/or knowledge of Quality System Requirements preferred.
• Strong verbal and written communication skills.
• Strong planning, organizational, and interpersonal skills.
• Ability to follow detailed instructions on new assignments.
• Working knowledge and experience in the use of computer and computer programs, such as Microsoft Office, File Maker, Adobe Acrobat, Oracle, and other ERP systems.

The employee may be required to handle hazardous materials (return shipments), acute judgment is expected in handling such materials.

This is a full‑time, non‑exempt position, Monday through Friday during standard business times. Flexibility to work overtime or non‑standard hours may be required at times.

Takara Bio USA, Inc. does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non‑merit factors.

Please note this job description may not cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. The US base hourly rate range for this full‑time position, expected to be located in San Jose, CA, is $37.00 - $40.00 USD.

This range may be modified at any time at our sole discretion. This base salary does not include additional bonus compensation and benefits. Learn more about benefits at … . Individual compensation packages are based on factors unique to each candidate, including job‑related skills, training, experience, qualifications, work location, and market conditions.