Quality Assurance Specialist Nights
Core
Guardian of patient safety and product excellence through rigorous GMP record review, batch release activities, and shopfloor oversight to ensure regulatory compliance.
Role type
Quality Assurance Specialist (Pharmaceutical Manufacturing)
Builds
High-quality pharmaceutical products (Drug Substance/Drug Product) for patients
Domain
Biopharmaceutical manufacturing and quality assurance
Required skills
GMP compliance, Root Cause Analysis (RCA), Change Control, Risk Management, Audit support, Quality documentation review, Manufacturing process oversight
Preferred skills
Process improvement, Quality investigations, Inspection readiness
Technologies
cGMP, GxP regulations, Quality management systems
Responsibilities
Conduct regular audits of production processes, Manage and resolve quality-related issues, Lead root cause analysis investigations, Participate in internal and external audits, Develop risk management strategies, Provide QA support to designated units
Seniority
Mid-level, hands-on IC
