Design Quality Assurance Engineer - Entry Level
A growing biotechnology/life sciences company has an opening for Design Quality Assurance Engineer - Entry Level. Our client is a leading provider of products and services to accelerate development of viro-immuno-oncology drugs.
Connect with us to learn more about this great opportunity.
- Provide quality engineering expertise to process/equipment validation, new business development and interface with customers during new product development
- Review and approval of appropriate controlled documentation (ex. validation protocols and reports, production related documents, nonconformities, validation deviations)
- Develop validation strategy based on understanding of risk to product and applicable regulatory requirements
- Qualify new equipment, facility changes and manufacturing processes
- Review and approve Change Orders
- Successfully attain budget/business objectives
- Comply with regulatory and industry standards
- Support other departments as needed
- Assist with internal audits as needed
- BS in Scientific Discipline or Engineering
- Previous experience in Quality Assurance or Quality Engineering in an FDA regulated industry - Medical Device / Pharmaceutical
- Previous experience in biology/ chemistry production processes – Preferred!
- Previous experience in process/ equipment validation – Preferred!
- Previous experience and knowledge working with FDA Quality System Regulation and FDA GMP
- Previous experience and knowledge of the following standards: GMP Guide for Active Pharmaceutical Ingredients, Pharmaceutical Development, Quality Risk Management, Pharmaceutical Quality Systems
- Previous experience with statistics or statistical process control concepts, conducting risk assessments
- Ability to lead projects and be a collaborative team player
- Skills to be successful in the role: self-starter, problem solving skills, multi-task, technical writing, communication skills, ability to organize and prioritize workload
Keywords: chemistry, biology, engineering, chemical engineer, quality, medical device, pharmaceutical, FDA, GMP, risk management, IQ/OQ/PQ, validation, pharma, statistics
"By applying to this position, you are confirming that you understand the requirements needed for this position, and further confirm that you possess the necessary skills and requirements, as outlined above".