Cypress HCM · 20 hours ago
Product Support Scientist
Cypress HCM is seeking a Product Support Scientist to support validation work for new products. The role involves laboratory testing, preparing clinical test specimens, and maintaining laboratory equipment while adhering to quality and safety guidelines.
Human ResourcesInformation TechnologyStaffing Agency
Responsibilities
Support validation work for new products, including laboratory testing utilizing VITROS analyzers
Prepare and handle clinical test specimens according to approved procedures, best practices, and safety requirements, including appropriate PPE
Perform pilot-scale formulations with biological materials, as needed
Operate and maintain laboratory equipment; complete all required documentation in real time (QC records, instrument logs, test records)
Independently execute laboratory experiments and assist with troubleshooting instrument and test failures, as needed
Review and analyze data; document conclusions and test summaries in appropriate quality records within the company's quality system
Ensure organization, documentation, and tracking of long-term studies with multiple factors, products, and conditions
Maintain a working knowledge of cGMP requirements and adhere to all quality, regulatory, and safety guidelines
This role involves both laboratory and computer-based work
Qualification
Required
Bachelor's degree in a scientific field (e.g., Chemistry, Biology, or equivalent) required
Strong written and verbal communication skills with excellent attention to detail required
Strong organizational skills and ability to manage complex, long-term studies required
Proficiency in Excel required
Preferred
Experience in an FDA-regulated industry and in validation for medical devices preferred
Familiarity with VITROS products and VITROS analyzers highly desired
Familiarity with biological formulations and processing techniques highly desired
Additional statistical analysis skills preferred