Quality Assurance Coordinator
: Job Details :

Details:L.J Gonzer Associates is looking for individuals to join our pool of qualified candidates for potential assignment as aQuality Assurance Coordinatorwith 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 closureIssue SCARs (Supplier Corrective Actions Investigations) to suppliers, follow through to completionChange quality status in ERP (SAP) as neededIssue nonconformances, CAPAs, Deviations, Conditional Releases as needed in support of the Quality SystemMaintain applicable SOPs and processesParticipate in and provide necessary data/metrics required for Quality meetingsAssist in investigations by review of batch records retain analysis, and Gemba walksDocument Processing:Review change requests and documentation for complianceProcess change requests and documents for review, approval, and issuanceEnsure revision control of all controlled documentsPurge obsolete documents per procedureCustomer Service:Assist internal customers with technical support and status inquiresFiling:File controlled documents as needed per procedureReporting & Analysis:Create weekly trending reports and metrics for complaints, nonconformances/DMRs, and others as appropriateDeliver departmental metrics as requestedAnalyze and plan upgrade strategies to ensure complianceAudits, Inspections, and Commitments:Participate in the organization and execution of audits and inspections, including personnel, requests, documentation, and process flowMaintain documentation and records in accordance with regulations and internal policiesJob RequirementsDetails:Associate's Degree preferred. Relative work experience in a GMP environment may be considered in lieu of degreeAt least 3 years in a Quality role in a GMP environmentProficient in Microsoft Office Suite, Internet Browsers, and Adobe PDF applicationsDocument control System, CAPA/Compliant Investigation, SAP working knowledge preferredAbility to prioritize daily workload, multitask, and shift scope to meet business needsability to work independently, cross-functionality, and within a team environmentPossesses a strong attention to detail and the ability to troubleshoot documentation issues with minimal guidanceAbility to participate effectively in audits and inspections