Duration
4 Months + (5-10 hours a week)
Job Description
Our client is looking for a senior level quality consultant to help look over the client’s current processes and procedures and dictate which QMS would be best for them and then help implement it. This is a company that builds platforms for companies to use to make their biologic or cell products. They currently have 3x the customers than they have space for and move from RnD to clinical quickly so they want to ensure there are no lapses in quality.
This resource will need to go over their current guidelines about how they approach their work and look for gaps or oversight of potential risks or regulatory concerns. This resource needs to be familiar with many different QMS’s and take a look at what the company does and help pick out the right QMS and load all info into it. They will also need to provide training to the team on how to use it, where documents go, where to pull templates from, etc. all in a quality manual. If this person has a technical background this work could go beyond training and document procedures and get into their cell culture/cell assembly work as well.
This is all pre-clinical and non GxP. Implementing a quality system is not a requirement for them, they just want to implement it to ensure everyone follows the same procedures.
Skills
- QMS
- Authoring quality manual, training and documentation procedures, risk assessment, etc
- PPE/Safety and best practices from a lab and data point of view
Nice to Have
- Technical knowledge of biologics and viral vectors, cell and gene therapy.
Education
- Experience outweighs degree
- Experience: 20+ years of quality
Remote: Quality Consultant (233858)
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