JT628 - QUALITY APPLICATIONS SPECIALISTS

Villalba, Puerto Rico

Temporary

Medical Device

Mid Level

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 related area
3+ years of relevant experience
Lean Six Sigma Green Belt Certification
Experience working with systems including Microsoft Office (Excel, Word, Outlook, PowerPoint, Project), Agile, ABRA Suite (HR), Maximo, MRO programs, SAP, TEDS, ComplianceWire, and Gallup online tools.
Hands-on experience in equipment qualification, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
Preferred experience in DOE (using Minitab), with additional skills in Computer System Validation (CSV), SOP development, and change control for medical devices.
Experience in process validation (from process characterization through OQ and PQ), statistical analysis, process FMEA, and first-time quality.
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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