Job Title: QA Associate I
Reports to: Senior Manager, Quality Assurance
FLSA Class: Nonexempt
Introduction to Job Post:
The QA Associate I role is responsible for providing compliance and regulatory support to the Quality Assurance department to help maintain the quality management system.
This position is office-based and reports to the Senior Manager, QA and is responsible for ensuring product and process conformance to applicable quality system requirements and ISO 13485 standards.
We are looking for an individual who is detail-oriented, enthusiastic, self-starter, collaborative, a team player, and eager to learn and grow.
- Responsible for implementation of routine and non-routine quality assurance projects, as assigned.
- Participates in quality and process improvement projects, as assigned.
- Perform QA and document control functions including Oracle data entry, COA generation, label processing and printing, organizing documents, scanning and uploading of records, and filing of paper records.
- Provides help in troubleshooting document control issues.
- Maintains product, quality, and/or regulatory information in relevant databases, as assigned.
- Periodically reviews and updates inspection and testing requirements; manages product databases to ensure continued accuracy and effectiveness.
- Limited responsibility for the review, release, and distribution of product technical documentation and for the implementation of documentation changes due to Engineering Change Notices.
- Creates reports on quality-related performance indicators.
- 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.
- This position does not have supervisory responsibilities.
Education/Certification, Experience, and Competencies:
- BA/BS degree in a scientific discipline or equivalent is required.
- Minimum 1-2 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 required.
- Strong verbal and written communication skills.
- Strong planning, organizational, and interpersonal skills.
- Ability to work independently on routine tasks and 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.
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.
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.