Job Information
Quality Consulting Group Quality Applications Specialists in Villalba, 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:
Will use Quality resources to support product transfer activities such as: Layout, Equipment Qualification, Test Method, Process Validation, Plan and Report development and approval.
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:
Bachelor's degree in Engineering or Science
Four (4) or more years of relevant experience
Experience as Quality Specialist in medical devices of pharmaceutical industry.
Experience processing regulatory approvals.
Experience with Computers Systems Validation and Process Validation.
Statistical Knowledge
Minitab / SAP experience
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.
Powered by JazzHR