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Quality Assurance Associate

Company: Kelly
Location: Fort Worth
Posted on: February 25, 2021

Job Description:

At Kelly, we believe in connecting people to work in ways that enrich their lives, and we are constantly striving to provide top talent with their next great career opportunity. We have partnered with a company in Fort Worth that provides medical devices to hospitals, nursing homes, and home health agencies. Currently, they have a need for a Quality Assurance Associate on a 6 Month Contract.--Pay rate range is between $25-$29 an hour, based on experience.Position Overview The Quality Assurance Associate is responsible for the development and revision of all controlled documentation and records. This role will engage in training programs, quality audits, regulatory inspections, product releases, quality incoming verifications, investigation management conducting complaint handling, root cause analysis, and corrective action definition to support the UMNA Quality Management System (QMS) objectives. The role will perform additional duties as required to support Regulatory Affairs and Quality Assurance (RA/QA) Management personnel on related tasks. Duties and Responsibilities --- Maintain and organize E-files and physical files for the RA/ QA Department. --- Responsible for document change control process, document distribution, archiving, and retrieving. --- Follow policies, SOPs, and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests. --- Maintain the flow of controlled documents and provide support for other functions through routing, review, distribution, approval, and release of documents. --- Participate in periodic review of QA procedures and forms, process improvement, and documentation improvement. --- Participate in the development and roll-out of document control tools, Electronic QMS, or Electronic Training program. --- Reviews documents and records for accuracy and compliance with GDP. --- Regularly update and maintain all QA related logs. --- Responsible for updating training matrixes and maintain training documentation for QMS related training for the organization. --- Support in internal audits, external audits, and regulatory inspections for compliance. This may require data gathering, escorting auditors during the audit. Assist with document retrieval /organization support during regulatory inspections. --- Complaint handling per QMS (21 CFR 820.198). --- Corrective Action and Change Control management. --- Responsible for product releases and QA incoming verification processes and documentations. --- Provide assistance to the RA/QA department to meet regulatory and compliance requirements. For Immediate Consideration, please email Eva at Eva.Harvey@kellyservices.com

Keywords: Kelly, Fort Worth , Quality Assurance Associate, Other , Fort Worth, Texas

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