Ensures regulatory compliance by completing the appropriate documentation pertaining to customer complaints, risk analysis, investigations. Support the health of the quality system by monitoring, trending and analyzing quality metrics, and reporting to management. Comply with all regulatory and quality systems standard requirements. Conduct and document quality department investigations. Prepares, reviews and analyzes appropriate regulatory documentation (e.g. Complaints, Risk Assessment, Technical Assessments, CAPA Projects).
Bachelor’s degree in engineering field and 3 years or more related quality experience
Ultimate Solutions Corp is an equal opportunity employer.
- Experience in quality assurance inspection, documentation auditing, record keeping, report compilation
- cGMP system and investigation of non-conformance in the pharmaceutical industry is preferred.
- Statistical Knowledge, DOE and Quality Process Control experience is preferred.