Senior Specialist I, Quality Assurance
Core
Support clinical trial projects and ensure compliance with regulatory requirements, GMP, and SOPs in a manufacturing environment.
Role type
Senior Quality Assurance Specialist (GMP/Pharmaceutical Manufacturing)
Builds
Clinical trial supplies and drug delivery products
Domain
Pharmaceutical manufacturing / Biologics
Deliverable
client delivery
Required skills
Regulatory compliance, GMP, deviation management, investigation management, SOP adherence, validation of testing methods, equipment calibration
Preferred skills
Six Sigma, ASQ certification
Responsibilities
Support clinical trial projects ensuring compliance with regulatory requirements, GMP, and SOPs; Provide regulatory expertise to the investigation and deviation management process; Participate in and maintain site audit readiness; Ensure testing methods are validated, equipment is calibrated, and results are accurate and reliable.
