QA Associate II
Job Title: QA Associate II
Reports To: Senior Manager, Quality Assurance
FLSA Class: Non-exempt
Position Summary/Objective:
The QA Associate II role is responsible for providing compliance and regulatory support to all aspects of the organization to help maintain the quality management system.
The QA Associate II is responsible for ensuring product and process conformance to applicable quality system requirements and ISO 13485 standards.
The QA Associate II is an on-site role located in San Jose, CA.
Essential Functions:
- 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 all products.
- 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.
Education/Certification, Experience, and Competencies:
- BA/BS degree in a scientific discipline or engineering (dependent upon the product line focus) is required.
- Minimum 3 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.
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 factor.
Disclaimer:
Please note this job description is not designed to 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.