Duration
3-6 Months
Job Description
The QA Contractor will be responsible for internal audits of the client’s SOP’s within the Quality, Quality System, Supply Chain, and Manufacturing departments. This candidate must be able to review and identify issues within the site and change things where they see fit. This person will also be responsible for handling vendor audits—communicating with them and ensuring that they are compliant both virtually and in person. Lastly this candidate should come from a broad background. The client is expecting them to create a training module from scratch that will combine processes for their GMP, GLP and GCP Operations. The perfect candidate will have a “jack of all trades” QA background, strong communication and the ability to adjust quickly if plans and duties shift urgently.
Skills
- 8-15 years of GXP experience (Biotech, Gene Therapy, Invivo)
- Experience working and reviewing SOP’s for Quality Systems Supply Chain, QC, Manufacturing, Facilities. Doing the QS review of SOP and Documentation (Veeva)
- Experience creating a Training Module to combine processes for GLP, GMP and GCP operations
- The candidate must do this from scratch
- Being able to train the staff with the training module is ideal
- Skilled in both internal and vendor audits
- Preforming internal audits, walking through area, looking at documentation
- Traveling to vendor audits if and when needed to make sure that their operations are fully GXP compliant
- PLUS: Working in within Gene Therapy Products, Invivo Gene Therapy, Viral Vectors is a (+)
Background
- Experience will outweigh Degree
Hybrid: QA Contractor (233063)
