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:

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.

Prepare project plans and project progress reports.

Support development, review and approve Computer System Validations protocols for the medical devices industry.

Support development, review and approve Computer System Validations reports with rigor and provide guidance where applicable

Support development, review and approve changes to work instruction impacted by changes in computer software.

Availability for 1st Shift, 2nd Shift, 3rd Shift or 4th Shift