Colorado Licensed QC Compliance Specialist

Job Summary

Focused on ensuring compliance within the Quality Control department, the full-time Colorado Licensed QC Compliance Specialist will manage change controls, deviations, and continuous improvement initiatives while collaborating with cross-functional teams in a remote work environment with occasional onsite activities.

Key responsibilities

• Oversee the writing and management of change controls, CAPAs, and document updates to ensure compliance with established procedures
• Collaborate with leadership and document writers to facilitate accurate and timely updates of Quality Control documents
• Serve as a Subject Matter Expert for technical reviews and ensure adherence to timelines for CAPA implementation and quality event records

Required qualifications

• BS in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field
• 6+ years of pharmaceutical cGMP laboratory experience with a Bachelor's degree; 3+ years with a Master's; or 2+ years with a PhD
• Experience in cGMP analytical testing of drug substances and products, preferably in a high-volume Quality Control laboratory
• Strong knowledge of Root Cause Analysis, ALCOA+ principles, and quality risk management
• Proficiency in quality event records and analytical instrumentation within the QC department