Job Opportunities in United States


November 1, 2024

QRC Group, LLC

Juncos

CONTRACT & FULL TIME


Process Development Scientist

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

  • Validation and documentation processes in a highly regulated environment.
  • Interpret and apply GLPs and GMPs.
  • Ability to apply a science-based approach to production.
  • Vision system technologies (strong knowledge).
  • Inspection/packaging Concepts.
  • 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.
  • Able to 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.
Requirements:
  • 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
  • Basic technical presentations
  • Dealing with and managing change
  • Analytical Problem Solving
  • Computer Literacy
  • Schedule development
  • Facilitation/Collaboration
  • Basic project management
  • Completion and follow-up
  • Specialized equipment/process expertise
  • Interacts effectively with a variety of communication and working styles
  • Ability to handle multiple projects at one time
  • Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.
  • Problem solving skills for the application of scientific and engineering theory
  • Skills in the development of hypotheses and approach
  • Working knowledge of financial analysis tools
  • Ability to delegate and manage the project work of others
  • Bilingual (Spanish/English)(Write/Speak)
Skills in the following areas:
  • Negotiation, persuasion and facilitation Collaboration
  • Project cost development
  • Conflict Resolution
  • Schedule and resources loading development
  • Flexibility to work off-hours
Job Types: Full-time, Contract
Schedule:
  • 8 hour shift
  • Day shift
  • Overtime
Education:
  • Bachelor's (Preferred)
Experience:
  • GLP's and GMP: 6 years (Preferred)
  • Validations: 6 years (Preferred)
  • vision system technology: 6 years (Preferred)
  • risk assessments: 6 years (Preferred)
  • characterization: 6 years (Preferred)
Language:
  • Spanish (Preferred)
  • English (Preferred)
Work Location: In person

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