Scope: To maintain the quality system and ensure compliance as required by the Quality System Regulations (QSR) and ISO Regulations. Areas of responsibility include but are not limited to are document review for finished goods, learning management system maintenance and document control support.
May include some or all of the following:
- Responsible for Finished Goods QA Release – including incoming Finished Goods
- Completes Certificate of Analysis or Certificate of Conformance to accompany customer orders
- Maintains Training Requirements in Electronic Learning Management System and assigns training tasks as needed
- Supports documentation and labeling function as required. Follows up on periodic reviews, change requests and document revisions within Electronic Documentation Management System
- Understands and adheres to all QSR, ISO, Safety, and Legal requirements.
- Consolidates and summarizes source data trending for Management Review.
- Supports Management Rep as required.
- Demonstrates commitment to the development, implementation and effectiveness of Sekisui Diagnostics’ Quality Management System per ISO, FDA, and other regulatory agencies.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Carries out duties in compliance with established business policies.
- Other related tasks and projects as required.
Education / Experience:
- High School Diploma and 3-5 years of related work experience preferred.
- Knowledge of Quality System and ISO regulations preferred.
Skills / Prerequisites:
- Highly detailed oriented
- Ability to work as part of a team
- Ability to deal with conflicts or stressful situations
- Expertise in Microsoft Office: Word, Excel.