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Process Development Specialist
hace 1 mes
As a Process Development Scientist at QRC Group, LLC, you will play a crucial role in the development and execution of processes and equipment characterization. Your working knowledge of pharmaceutical and biotech processes will be essential in this position.
Key Responsibilities- Validation and documentation processes in a highly regulated environment.
- Interpret and apply GLPs and GMPs.
- Apply a science-based approach to production.
- Develop and execute 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.
- 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).
- Negotiation, persuasion, and facilitation collaboration.
- Project cost development.
- Conflict resolution.
- Schedule and resources loading development.
- Flexibility to work off-hours.
