QA Analyst
Core
Ensuring quality and compliance in sterile pharmaceutical manufacturing through batch record review, deviation management, and regulatory inspection readiness.
Role type
Quality Assurance Analyst (GMP Manufacturing)
Builds
GMP-compliant sterile injectable products for CDMO clients
Domain
Pharmaceutical manufacturing / Biotechnology / GMP-regulated environment
Required skills
GMP knowledge, batch record review, deviation management, CAPA initiation, root cause analysis, change control, quality risk management, environmental monitoring support, audit support
Preferred skills
Sterile/aseptic manufacturing familiarity, APS/media fills knowledge, contamination control understanding, validation support
Technologies
Liquid fill-finish systems, lyophilization equipment, environmental monitoring systems
Responsibilities
Review batch records and GMP documents for accuracy and compliance; Initiate and support deviations, investigations, CAPAs, and change controls; Assist with root cause analyses and quality risk assessments; Provide QA oversight of sterile manufacturing operations; Support environmental monitoring and media fill activities; Collaborate with Manufacturing, Engineering, and Validation teams to address quality concerns.
Seniority
Mid-level, hands-on IC