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QA Associate I - San Jose, United States - GenomeWeb
Description
2560 Orchard Parkway, San Jose, CA 95131
San Jose , CA 95131
United States
Job Description
Job Title: QA Associate I
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, andoftenhope Together we can improve the human condition through biotechnologyand That's Good Science
How this role drives the company forward:
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.
The QA Associate I 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, manage company preventive maintenance and calibration program, generating and review of product documentation (i.e.: labels, COA, COO), conducting incoming inspections, database maintenance, support document control, customer request and new product transfer activities, and making recommendations for improvement.
What will you do:
Responsible for implementation of routine and non-routine quality assurance projects, as assigned.
Participates in quality and process improvement projects, as assigned.
Provides help in troubleshooting document control issues.
Maintains product, quality, and/or regulatory information in relevant databases, as assigned.
Creates reports on quality-related performance indicators.
Works with the SDS team in generating Safety Data Sheets for products, as assigned.
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.
How will you get here?
BA/BS degree in a scientific discipline or equivalent is required.
Minimum 0-2 years of experience in the life science or medical device/IVD industry in a Quality Assurance role.
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, FileMaker, Adobe Acrobat, Oracle, and other ERP systems.
Physical Demands/Work Environment:
The employee may be required to handle hazardous materials (return shipments), acute judgment is expected in handling such materials.
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 $ $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.
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