QA Associate II

Job Title: QA Associate II

Reports to: Director, Quality Assurance

FLSA Class: Nonexempt

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!

At Takara Bio, we know that every experimental decision has an impact. Choices matter, from design to data analysis. We create best-in-class products that get the job done. In your hands, what do those research reagents and kits create? Something powerful: knowledge, understanding, and-often-hope! Together we can improve the human condition through biotechnology…and That's Good Science!

How this role drives the company forward:

The QA Associate II role is responsible for providing support to the Quality department in the maintenance and management of the company's quality management system under general guidance and increased independence over time.

The QA Associate II ensures product and process conformance to applicable quality system requirements and ISO 13485 standards by carrying out tasks independently as per documented procedures and working closely with other departments to facilitate required actions.

The QA Associate II is an on-site role located in San Jose, CA.

How you will make an impact:

In this role, you will perform tasks in support of the quality system maintenance such as implementing quality assurance procedures and work instructions, items and BOM data entry, database maintenance, manage company preventive maintenance and calibration program, generate and review of product documentation, support document control, customer request and new product transfer and continuous quality improvement activities.

What will you do:

• Participates in quality and process improvement projects related to product quality, site compliance, validations, internal and supplier audits, and CAPA system coordination. Specific tasks and actions are dependent upon the product line assigned to the position.

• Supports product and design transfer activities for new or modified products.

• Maintains regulatory information in relevant databases with regards to tariff code information, IATA and safety data sheet requirements, and import/export requirements, as assigned.

• Writes and updates procedures as needed, manages completion of document changes, and maintains change control system and processes.

• Works with the SDS team in generating Safety Data Sheets for products, as assigned.

• Periodically reviews and updates inspection and testing requirements; manages product databases to ensure continued accuracy and effectiveness.

• Responsible for the review, release, and distribution of product technical documentation and for the implementation of documentation changes due to Engineering Change Notices.

• Performs review and/or approval of manufacturing instructions and other supporting documentation for accuracy, completeness, and compliance, as required.

• 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 moderate to complex issues and independent decisions on simple issues in collaboration with key stakeholders and in alignment with company policies.

• Maintains documentation for areas of responsibility.

• This position does not have supervisory responsibilities.

How will you get here?

• BA/BS degree in a scientific discipline or engineering (dependent upon the product line focus) is required.

• Minimum 2 years of experience in the life science or medical device/IVD industry in a Quality Assurance role, supporting product life cycle of either reagents or instruments, dependent upon the product line focus.

• Experience with ISO 9001/13485 and knowledge of Quality System Requirements required.

• Strong verbal and written communication skills.

• Strong planning, organizational, and interpersonal skills.

• Ability to work independently on routine tasks, establish priorities to meet multiple demands, and prepare written information in a clear and concise fashion.

• Working knowledge and experience in the use of computer and computer programs, such as: Microsoft Office, FileMaker, Adobe Acrobat, Oracle or a similar ERP system.

Physical Demands/Work Environment:

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

A few other details:

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.

AAP/EEO Statement:

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.

Additional Information about the role:

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 $45.00 - $48.00 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 https://www.takarabio.com/about/careers/company-benefits. Individual compensation packages are based on factors unique to each candidate, including job-related skills, training, experience, qualifications, work location, and market conditions.