What are the responsibilities and job description for the SR Associate, Gene Therapy Quality Control position at Orbis Clinical?
Job Title : Contract Senior Associate, Gene Therapy Quality Control
Location : Andover, MA (Onsite 5days / week)
Contract : 12 months
The Importance of the Role
- This individual will support quality control activities to support a centralized program management of reference standards and critical reagents used across a wide network of QC labs in the testing and release of clinical and commercial products.
- The work involves generation and qualification of critical reagents, maintaining inventory, qualification, stability tasks to support AAV-based product testing at Andover company site and at contract labs. The individual will conduct laboratory support processes such as maintaining cell cultures. The candidate must have hands-on experience in cell culture techniques, in vitro Potency, Western blot (automated preferred), protein extraction, and protein quantification methods. Experience with qPCR, and / or ddPCR are also desired skills. The work involves performing assays in a QC-GMP BSL-2 environment.
- The individual will support the team manager in managing quality events (OOS, OOT, Deviation, Change Control, etc.) and data trending. All aspects of this position would involve working in a GMP compliant manner.
- All aspects of this position involve working in a GMP-compliant manner.
Primary Responsibilities Include :
