Job Information
Quality Consulting Group Validation Specialist in Jayuya, Puerto Rico
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:
Developing and managing GMP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance testing, traceability matrix, system, Validation Reports, SOPs, Change Control Documentation, and Risk assessment reports.
Performs routine engineering assignments of related tasks which are typically a focused portion of larger projects. These tasks provide experience and familiarization with the engineering staff, methods, techniques, theories, Corporate and division SOP's, policies and projects.
Document development work including writing specifications for manufacturing or scientific test results.
Solve routine design and engineering tasks with some assistance.
Solve problems with periodic monitoring.
Assists in the preparation and participation in technical reviews and responsible for organizing data and preparing appropriate documentation for assigned projects.
Collect data and technical reports/ assessments.
Qualifications:
Bachelors Degree in Engineering or Science
Two (2) or three (3) years of previous experience
Must have experience in validations of Manufacturing equipment.
Ability to discuss normally encountered technical or project management issues, both verbally and in written form.
Ability to work as a collaborative team member.
Ability to solve routine design, engineering problems.
Ability to work on protocol development and execution.
Communicate effectively at all levels.
Availability for 1st shift
Quality Consulting Group, LLC 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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