Quality Associate (Rochester, NY)

The Quality Associate is responsible for creating, auditing and reviewing documents related to multiple systems, projects and processes.

Major duties

–Audit and review project/process documents and provide feedback to the process owners.

–Create detailed plans for validating various computer systems and software, while considering all elements.

–Coordinate, perform, review, and document the validation and qualification of systems.

–Assist with the implementation of system upgrades for new and existing processes and studies.

–Identify system issues and work with appropriate process owners/departments to investigate and resolve.

–Train personnel on new systems, system upgrades and bugs found during the system validation process.

 Essential qualifications

–Familiarity with Microsoft Windows client operating systems, Microsoft Office Word and Excel.

–A detail-oriented multitasker with the ability to manage deliverables effectively across multiple departments and handle multiple projects at one time.

–Strong verbal communication, technical writing, and process improvement skills.

Preferred qualifications
–Associate’s degree or higher

–Knowledge of computer system validation, system and network administration is desirable

–Understanding of FDA regulations like 21CFR Part 11, cGMP, GDP, GCP

–Experience in an environment with standard operating procedures.

Resumes to jobs@icardiac.com