HistoWiz is a biotechnology company located in New York that automates histology for biomedical researchers in academia and industry. Our intelligent tissue platform facilitates the collaboration between scientists and clinicians, and enable discovery by allowing search and comparison of cancer histopathology data across different laboratories and hospitals around the world. Our mission is to fight cancer cooperatively instead of individually.
We are looking for a quality assurance specialist to join our growing team and help ensure quality compliance for our expanding workload. Main duties include:
- Writing and reviewing Standard Operating Procedures
- Training staff on quality compliance
- Maintaining and ensuring quality compliance for staff training files, master schedule, job descriptions, CVs, etc.
- Performing in-phase inspections in support of writing inspection reports, following up on observations/CAPA, and preparing QA statement
- Providing QA support for validations including reviewing protocols and reports
- Working collaboratively with staff responding to and resolving deviations and incidents
- Following through on corrective and preventative actions from deviations and audit observations
- Maintaining databases for investigations, audit observations and CAPA
- Assist clients and regulatory agencies with audits, addressing audit reports and following up on observations/CAPA
Requirements
- A BS and/or MS degree in Science and 2 years of related experience in Quality Assurance or a related area
- Prior audit and quality review experience
- In-depth knowledge and experience with quality regulations and industry standards (EPA, OECD, FDA, EU guidance)
- Excellent communication skills and work well under pressure in a team environment
Additional Experience:
- Experience in histology, histotechnology, and IHC
- Lab management experience
Benefits
As a regular employee of the Company, you will be eligible to participate in those Company-sponsored benefits generally made available to all employees.