Process Development Scientist - Juncos, Puerto Rico - QRC Group, Inc

Descripción

Process Development Scientist with working knowledge of pharmaceutical/biotech processes.

Duties: ​

• Validation and documentation processes in a highly regulated environment.
• Operate specialized laboratory equipment and computers as appropriate.
• Interpret and apply GLPs and GMPs.
• Apply a science-based approach to production.
• Development and Execution of Processes/Equipment Characterization
• Establish Testing Strategies
• Design / Development of Characterization Protocols
• Technical Reports Development
• Validations, and technical reports to support SATs executions, document generation and challenge validations strategies.
• Risk assessments and QRAES knowledge, to support risk assessments activities.
• Develop solutions to routine technical problems of limited scope.
• Comprehensive understanding of validation protocol execution requirements. In-depth knowledge of validation processes as applied to new equipment installations.

• Doctorate degree or Master's degree and 5 years of Scientific experience or
• Bachelor's degree and 6 years of Scientific experience
  Basic technical report writing and Validation Protocol Writing
• Verbal communication
• Basic technical presentations
• Personal Organization
• Dealing with and managing change
• Technical (Equipment Specific)
• Analytical Problem Solving
• Completion and follow-up
• Computer Literacy
• Schedule development
• Facilitation
• Collaboration
• Bilingual (Spanish/English)
• Flexibility to work off-hours

All your information will be kept confidential according to EEO guidelines.