We are currently working with a small to mid-sized ImmunoOncology company focused on biological therapies. My client has 10+ clinical trials, with 4 clinical trials being in Phase 2 or further. With multiple sites in the United States and one overseas, they're looking to add headcount to their Pennsylvania location. We are looking for a QMS Specialist on a contract-to-hire basis.
Responsibilities of the role:
- Create, review, and approve GMP-related documentation including but not limited to SOPs, batch records, specifications, master manufacturing records, analytical methods, labeling, protocols, etc.
- Approve and write deviations while evaluating CAPAs and effectiveness checks.
- Proficiency in QMS workflows, systems, and procedures
- Knowledge of applicable US FDA requirements and expectations for API development, production, and distribution
- Good understanding of GMP (Good Manufacturing Practices) but prior GCP (Good Clinical Practices) is highly desirable
Qualifications:
- Bachelor's degree in Life Science or related field
- 5+ years of GMP experience
- 2+ years of GCP experience
- 5+ years of pharmaceutical/ biotechnology experience
