Job Description
Reporting to the Vice President, Quality, we are looking for Senior Specialist ISO Quality who has experience in ISO 9001:2015. It is preferred the successful candidate will have demonstrated the ability to work in a laboratory setting in the life science field.
Key Responsibilities
- Manage the ISO Quality System supporting Tube and Reagents and R&D Services. This includes, but is not limited to:
- Maintaining the ISO Quality Manual and the supporting Quality System Standard Operating Procedures
- Training personnel on the ISO Quality system and their responsibilities in executing ISO Quality processes.
- Supporting the Deviation and CAPA process and approving Deviation Investigations and CAPA plans and completion
- Support Non-Conforming Material Investigations and approve final Investigations and Material Disposition
- Review and approve production records and approve product disposition
- Providing input for and participating in Management Review
- Keeping Risk Register up to date
Qualifications and Preferred Skills
- B.S. preferred in Biochemistry, Chemistry, or a related field
- 5-7+ years’ experience
- Excellent written and oral communication skills
- Cross-functional experience working across departments in an organization
- Strong organizational skills with ability to work in a team and multi-task
- Demonstrated Knowledge of the ISO Quality Standards and Processes
- Demonstrated Communication and Collaboration skills to effectively provide training and coaching for ISO quality processes, update Management on key issues and risks.
- Knowledge of the product to perform accurate quality assessments
- Attention to detail
- Analysis, critical-thinking and problem-solving skills to review systems, find flaws and pose solutions
- Experience with ETQ Reliance application a plus