Quality Systems Coordinator

Quality Assurance Associate

Kelly Science & Clinical | Fort Washington, PA

Position Details

• Job Title: Quality Systems Coordinator
• Location: Fort Washington, PA
• Work Arrangement: Onsite
• Pay Rate: $27/hr
• Schedule: Monday–Friday, 8:00 AM–4:30 PM
• Hours: 40 hours per week
• Job Type: Long-Term Contract, 12+ months

Position Overview

Kelly Science & Clinical is seeking a Quality Systems Coordinator to support quality operations within a pharmaceutical and over-the-counter (OTC) environment. The Quality System Coordinator is responsible for executing Document Management, Retention and Learning Management activities in support of ongoing projects. Primary responsibilities include the data entry, development, coordination and maintenance of all site documentation and training activities. This position requires a thorough knowledge of documentation, training and retention requirements.

Key Responsibilities

•

Perform Learning Management System (LMS) transactions including user, item and curricula management, report generation and maintenance of content and completions.

• Monitor system through reporting functions to drive completion of outstanding items.
• Perform document control activities to ensure GMP documents (controlled documents, logbooks) are managed as required by SOP and regulatory requirements.
• Perform operational activities, including document issuance, reconciliation, review and processing in the document management system. Provide support for the development of document templates, technical editing and formatting as needed.
• Monitor system/workflow documentation and drive completion of tasks/outstanding items and ensure compliance
• Ensure adherence to the corporate Records Retention Program and maintain site Records Retention Schedules. Execute local and corporate SOPs to ensure chain of custody and traceability of all GMP records.
• Support stakeholders by performing database searches, file retrieval, scanning & copying.
• Serve as an administrator in the Electronic Records Management System (ERMS) which includes entering records, querying the system, filing and reporting metrics. Support and/or perform system validation/migration activities. Monitor functionality and communication between systems and related application.

Required Qualifications

• Associate’s degree or equivalent work experience.
• 0-2 years of experience in a pharmaceutical cGMP/manufacturing environment.
• Proficiency with MS Office, including Word, Excel and PowerPoint, Adobe, SharePoint and ability to learn new systems

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