Quality Assurance Specialist
Current- Managed the receiving, sampling, and submission of raw and packaging materials for quality testing.- Oversaw Quality Management System documentation.- Ensured compliance with cGMP, USFDA, and Health Canada policies and regulations.- Conducted in-line and in-process monitoring checks.- Monitored the status of raw and packaging materials, identifying required parameters.- Authored packaging specifications, including oversight of quality standards.- Authored and… Show more - Managed the receiving, sampling, and submission of raw and packaging materials for quality testing.- Oversaw Quality Management System documentation.- Ensured compliance with cGMP, USFDA, and Health Canada policies and regulations.- Conducted in-line and in-process monitoring checks.- Monitored the status of raw and packaging materials, identifying required parameters.- Authored packaging specifications, including oversight of quality standards.- Authored and maintained raw material and packaging reports of analysis.- Determined certificate of analysis requirements to ensure materials met physical, chemical, and microbial limits.- Ensured specifications were up-to-date with all applicable regulations and pharmacopoeias.- Supported regulatory filings related to specification creation. Show less