Quality Assurance Specialist
hace 1 mes
We are seeking a skilled Process Validation Specialist to join our team at Validation & Engineering Group, Inc., a leading services supplier in the pharmaceutical, biotechnology, chemical, food, and medical devices industries.
The successful candidate will be responsible for ensuring the highest quality standards in manufacturing processes. A key aspect of this role is to develop, execute, and validate protocols for various processes, including design documentation, installation qualification, operational qualification, performance qualification, deviations, and reports generation.
To excel in this position, you should have a Bachelor's Degree in Science or Engineering and a minimum of 3 years of experience in direct pharmaceutical, medical device, or biotechnology industries. You must be fully bilingual (English/Spanish) with excellent oral skills and proficient in MS Windows and Microsoft Office applications.
A strong understanding of cGxP regulations and their application to regulatory compliance is essential. Additionally, you should have knowledge of SDLC, risk assessment, data integrity, factory acceptance testing, and site acceptance testing. Strong technical writing skills and investigation processes are also required.
As a Process Validation Specialist, you will work extended hours, potentially on weekends and holidays. The estimated annual salary for this role is around $85,000-$110,000 depending on your qualifications and location.
We offer a competitive compensation package and opportunities for growth and development. If you are a motivated and detail-oriented individual with a passion for quality assurance, please submit your application for this exciting opportunity.
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