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Quality Assurance

The Fountain Group

Posted on: 20 Mar 2024

Job Location: Houston, US

Job Description:

Job Description:

Perform quality audits of our quality management systems and processes. Administer the Trackwise ACE system by entering, querying, and monitoring data to support the site internal audit program. This includes opening, troubleshooting, and communicating the status of IT support tickets. Initiating and following up on requests for new TrackWise ACE users. Assist with the implementation of the new audit system, Siemens. Follow up on outstanding Audits, audit CAPAs and effectiveness checks by contacting and reminding auditors, approvers, and owners of upcoming due dates, facilitate use of the TrackWise ACE system for all auditors, auditees, and management. React to corporate procedure (CORP) revision notifications by reviewing, assigning actions in the TrackWise CAPA system, and coordinating with the assignees. Follow up and remind assignees to ensure CORPs are assessed and implemented at the site before the global due dates. Administer the Visuant system (metric database) including adding new users, updating users, and assisting with metric creation, manipulation, and maintenance as needed. Gather from various subject matter experts the required monthly metrics for our Alcon Quality Analytics reporting. Respond to quarterly Regulatory Intelligence reports by reviewing identified standards, coordinating with compliance leadership, and assigning actions to subject matter experts in the TrackWise CAPA system. Follow up and remind assignees to ensure standards are assessed and implemented at the site in a timely manner. Assist with coordination, set up, planning, and preparation leading up to and during health authority, notified body, and corporate audits. Update, maintain, improve Share sites for compliance teams. Query systems for metric reporting. Perform ad-hoc training, share best practices, and coordinate assistance for new or struggling subject matter experts who need assistance using TrackWise ACE, TrackWise CAPA, performing gap assessments, or improving procedures and processes.

Qualifications:

Pay rate $40-44
Quality Assurance Audit experience
Document Control
Experience in GMP industry
Microsoft Excel - proficient to expert
Microsoft Word - proficient
Microsoft SharePoint design- proficient to expert
Microsoft PowerPoint - proficient to expert
TrackWise is a plus not required
Knowledge of industry regulations, ISO 13485, MDSAP, MDR is a plus not required

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