Quality Assurance Coordinator

apartmentGonzer Associates, L. J. placeWest Nyack calendar_month 

L.J Gonzer Associates is looking for individuals to join our pool of qualified candidates for potential assignment as a Quality Assurance Coordinator with our client based in West Nyack, NY.

This position will perpetuate Enterprise
  • wide Quality and Regulatory compliance and continuous improvement through assisting with the implementation and maintenance of robust quality systems and processes.
This position will report to the Senior Manager of Quality Assurance.
System Management:-Keep user database current (CAPAs, Change Control, Deviations, Customer Complaints)-Manage DMR database and processes to closure
  • Issue SCARs (Supplier Corrective Actions Investigations) to suppliers, follow through to completion
-Change quality status in ERP (SAP) as needed-Issue nonconformances, CAPAs, Deviations, Conditional Releases as needed in support of the Quality System
  • Maintain applicable SOPs and processes
-Participate in and provide necessary data/metrics required for Quality meetings-Assist in investigations by review of batch records retain analysis, and Gemba walks Document Processing:-Review change requests and documentation for compliance
  • Process change requests and documents for review, approval, and issuance
  • Ensure revision control of all controlled documents
-Purge obsolete documents per procedure Customer Service:-Assist internal customers with technical support and status inquires Filing:-File controlled documents as needed per procedureReporting & Analysis:-Create weekly trending reports and metrics for complaints, nonconformances/DMRs, and others as appropriate
  • Deliver departmental metrics as requested
-Analyze and plan upgrade strategies to ensure compliance Audits, Inspections, and Commitments:-Participate in the organization and execution of audits and inspections, including personnel, requests, documentation, and process flow
  • Maintain documentation and records in accordance with regulations and internal policies
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