QC Compliance Coordinator
Core
Coordinate QC compliance activities, ensure adherence to GMP/GLP and data integrity standards, and support continuous improvement of quality systems in a pharmaceutical QC laboratory.
Role type
QC Compliance Coordinator (IC)
Builds
Quality control systems, compliant laboratory operations, and regulatory-ready data integrity frameworks.
Domain
Pharmaceutical manufacturing / Quality Control / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP and cGLP knowledge, data integrity (ALCOA) implementation, SOP review and approval, LIR/QAR management, risk assessment, GEMBA execution, nitrosamine impact assessment, team coaching, capacity planning.
Preferred skills
Statistical analysis, LIMS (Empower) proficiency, AI tool usage (generative AI), critical thinking, organizational skills.
Technologies
Empower, Microsoft Office, LIMS, Generative AI tools (ChatGPT, Copilot)
Responsibilities
Review and approve QC SOPs, manage LIRs and QARs, perform data integrity GEMBAs, act as site SME for inspections, support new program implementation, coach the quality team, manage nitrosamine assessments.
Seniority
Mid-level, hands-on IC
