Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Quality Specialist - CAPA Implementation

Qualifications:

• Bachelor's Degree in Engineering or Science Field
• Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Must be proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• Experience with CAPA processes.
  • Knowledge of systems such as: Windchill, Ecapa, MES, or BMRAM.
  • Experience in risk management and line clearance.
  • Experience with change assessments, process validations, ESQ and software validations.
  • Previous experience with quality assurance (Required).
• Available to work extended hours, possibility of weekends and holidays.