Lead Specialist, Quality Operations
- You will be overseeing not only batch review, but also the resolution of quality systems which will be encountered during external manufacturing as well as testing of company products.
- You will need to maintain an external manufacturing vendor relationship, as well as communicate to support both efficient and compliant processes.
- You will be responsible for the management of analysis, complex problem solving, data review, and identification trends.
- You must ensure that any and all documentation is up to date with cGMP regulations as well as industry guidelines,
- You will be responsible to track and trend both Batch execution at CMO's as well as quality system generation at CMO's and CTO's.
- You will support the revision, development, and implementation of corporate quality systems.
- You will be responsible for the preparation and review of investigations, OOOS results, quality system documentation associated with deviations, and CAPA action plans.
- A background in processing and upstream manufacturing, and cellular therapy collection is preferred, but not required
- You will need a BA/BS, as well as 5-8 years in Quality Assurance.
- You will need experience with external manufacturing quality oversight.
- You should have experience with process mapping, process improvement tools, and contract manufacturing.
- You will need to have the ability to interact with contract testing and contract manufacturing organizations, including resolving, identifying, and communicating complex issues.
- Must have the ability to demonstrate project management skills
- You will need experience with change control, disposition, deviation investigations, and process improvements.
- Must have the ability to communicate both above and below level in a way that caters relationship building, this will also be needed while dealing with outside vendors.
- Must obtain a strong knowledge of quality systems, GxP regulations, and guidance documents.
Sthree US is acting as an Employment Business in relation to this vacancy.