Quality Engineer/Controlled Substance Program Lead
Core
Ensure quality excellence and regulatory compliance to DEA across manufacturing operations while maintaining robust quality management systems.
Role type
Quality Engineer III and Controlled Substance Program Lead
Builds
Manufacturing operations compliant with GMP, ISO, and DEA regulations
Domain
Pharmaceutical/Medical Device manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP requirements knowledge, ISO 13485/9001 standards expertise, DEA regulations knowledge, CAPA and deviation management, Change control, Risk management and FMEA, Document control, Internal and external auditing, Validation and qualification protocols
Preferred skills
ASQ Certifications (CQE/CQA), Engineering/Life Sciences/Chemistry background
Technologies
Quality management systems/software, Microsoft Office
Responsibilities
Oversee Controlled Substance Program compliance, Investigate and resolve quality issues, Conduct risk assessments, Manage CAPA activities, Support internal and external audits, Drive continuous quality improvement initiatives
Seniority
Mid-level, hands-on IC
