QA Operation Senior Specialist, QC Lab

Role Summary

Responsible for independent QA oversight of QC laboratory operations (chemical and microbiology, stability), ensuring compliance with GMP, Data Integrity (ALCOA++), and site quality systems. Contributes to Contamination Control Strategy (CCS) and supports aseptic assurance and inspection readiness.

Key Responsibilities

• Provide QA oversight of QC laboratory activities (chemical, microbiology, stability)
• Ensure compliance with GMP, SOPs, and approved methods
• Oversee microbiology activities including EM, sterility, bioburden, endotoxin
• Support CCS implementation and review EM trends and contamination risks
• Independently review analytical and microbiological data (ALCOA++)
• Support batch release and review CoA
• Participate in deviation, OOS/OOT, EM investigations and CAPA
• Provide oversight for method validation, EM methods, and QC systems
• Review and approve QC-related GMP documentation
• Support regulatory inspections and audits
• Identify recurring issues and support continuous improvement

Qualifications

Bachelor degree or above in Microbiology, Chemistry or related field

12+ years Quality experience in GMP environment

Experience in microbiology lab or aseptic support preferred

Technical Competencies

GMP knowledge (NMPA/FDA/EMA)

Analytical and microbiology testing

Environmental Monitoring and CCS

Data Integrity (ALCOA++)

Expectations

• Works independently in QC/Micro QA scope
• Provides sound QA decisions for routine activities
• Identifies risks and escalates complex issues
• Understands microbiological risks and EM trends
• Acts as reliable QA partner to QC