Senior Quality Analyst (2nd & 3rd shift)
Core
Implementing and maintaining the effectiveness of the Quality System for pharmaceutical/biotechnology manufacturing operations.
Role type
Senior Quality Analyst (Manufacturing)
Builds
Ensures compliance with GMP and regulatory standards for biological products.
Domain
Pharmaceutical/Biotechnology Manufacturing
Deliverable
client delivery
Required skills
Quality system management, GMP knowledge, risk management, investigation leadership, product impact analysis, change management, statistical analysis, EHS compliance
Preferred skills
Masters degree in Science
Technologies
CAPA systems, calibration systems
Responsibilities
Support routine operations to ensure quality goals are met, lead investigations and risk evaluations, approve SOPs and change management documents, oversee manufacturing operations for procedure alignment, support new product introduction activities, participate in Validation Review Board
Seniority
Senior, hands-on IC
