QMS Consultant GLP Cell Based Assay Lab
Share
Job Location:
San Diego, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
19 days ago
Vacancies:
1 Vacancy
Job Summary
o This client is a toxicology lab services group focused on drug profiling using their 3D bioprint tissue technology. The company created 3D cell models of disease. They have a relatively new GLP lab.
What is the project the contractor will be working on
o This contractor is tasked with implementing and developing a new QMS for the GLP cell based assay lab in San Diego CA. The client has not yet picked out the software (Veeva Oracle etc.)
Daily duties of the contractor
o Step one of the project is for the contractor to evaluate the GLP cell based assay lab and create a gap analysis to assist with project planning for the development and set up of the new QMS.
o Through this gap analysis they will work with the clients internal project team to create timelines and steps to implement a new QMS into the GLP lab.
o After gap analysis and project planning with the team this resource will create CAPAs SOPs and general documentation following GLP guidelines for compliance of the QMS.
o Most of the technical writing will relate to drafting and editing of SOPs for the GLP cell based assay lab equipment documentation and log books.
o Once the QMS is implemented the consultant will help with QMS related operations for the GLP lab.
Skills:
- 10-20 years of experience as a QMS director lead or manager.
- Prior experience setting up a new QMS system for a GLP cell-based assay lab. This consultant must have previous experience specifically working on GLP cell-based assay labs due to the nuances of the environment and FDA specific requirements.
- Previous experience drafting SOPs log books and equipment related documentation
- Prior experience drafting CAPAs for a new QMS in a GLP lab setting
- Previous experience leading QMS project meetings and steering committee updates.
