Ultimate Solutions Corp. is a trusted provider of packaging industrial automation, serialization and compliance for the Life Science Industries in Puerto Rico, United States and Europe. Over a decade, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices, and logistics markets.
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 related field with 3+ years or more of experience in Quality & Validation or related.
REQUIREMENTS & SKILLS
Ultimate Solutions Corp is an Equal Opportunity Employer.
- Experience in Quality, validation, process, or related engineering experience.
- Ability to investigate quality problems and to apply sound technical judgment to develop potential solutions.
- 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.
- Change Control
- Experience with validation documentation.
- Problem Solver
- Fully Bilingual (verbal and written)