Quality Assurance Specialist
hace 2 semanas
Mentor Technical Group is a world leader in life science engineering and technical solutions. We provide a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. Our team is dedicated to ensuring compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines.
Job Summary:
We are seeking a highly skilled Quality Assurance Specialist to join our team. The successful candidate will serve as a focal point for Facility commissioning & qualification (C&Q) and computer system validation (CSV) in support of the delivery of capital projects.
Responsibilities:
- Work on multi-discipline engineering capital project teams, as well as other project-related, cross-functional teams with representatives from departments throughout the organization.
- Project management tools, processes, and principles to enable successful project execution.
- Manage assigned project goals within scope, on budget, and on schedule.
- Measure and report project execution progress.
- Decision-making and make influential recommendations regarding best options.
- Validation Life Cycle, Reports and Master Plans.
- Communicate proactively with stakeholders and senior management regarding progress, issues, and plans for resolution.
- Development of C&Q/CSV Strategies.
- Review C&Q/CSV documents prepared by others.
- Develop and execute C&Q/CSV for special projects.
Requirements:
- Bachelor Degree in Science, Engineering, Computer Science, or related discipline.
- Must have five to seven years of experience in C&Q Lifecycle, CSV Lifecycle, Equipment/Facilities/Utilities Commissioning and Qualification, QA Systems, for the pharmaceutical, biotechnology and medical device industries.
- Fully bilingual (Spanish and English).
- Great interpersonal, initiative and leadership skills.
Working Environment:
The employee is regularly required to use hands to finger, handle, feel, or operate equipment's, tools, or controls. The employee frequently is required to stand, walk, talk, or hear; sit; climb or balance, stoop, kneel, crouch or crawl; and smell. The employee may lift and/or move up to 25-35 pounds and occasionally lift and/or move up to 50 pounds.
Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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