JT250 - QUALITY APPLICATIONS SPECIALIST

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA

Responsibilities:

•  Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
• Coordinates activities with clients, programmers/developers and operating personnel, domestic and, as appropriate, global.
• Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.
• Reports on the status of validation activities to fulfill regulatory requirements.
• Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
• Performs system administration and configuration of quality information technology systems.

Qualifications:

• Requires a Bachelor degree in Science or Engineer
• And minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
• Experience Process validation for New Product Introduction
• Problem solving method
• Risk assessment
• Ability to use statistical techniques to analyze data
• Capable of developing/reviewing/approving test plans and reports experience in medical devices manufacturing
• Interpersonal Skills
• Investigate and collaborate in the investigation of atypical events to support product disposition PFMEA
• Analytical and Problem-Solving Skills
• Applied statistical analysis
• Investigation and root cause analysis skills
• Technical writing knowledge.
• Process Validation and Computer software validation knowledge
• Availability for 1st shift