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In this role, you will work together with operations to plan, coordinate, and maintain Quality Assurance in compliance with all policies, procedures, customer specifications, and regulatory requirements. You will work collaboratively with the laboratory management team to improve overall laboratory performance.EAG Laboratories operates in accordance with International Traffic in Arms Regulation ITAR. Quality Manager must be a US Person (Citizen or Permanente Resident) as this person will be exposed to managing, sharing, safeguarding, and disseminating technical information in accordance with policy and law ( ITAR, 22 CFR §120-130).Essential Job Functions:Works closely with operations to ensure daily operations follow policies, procedures, customer requirements, and local, state, and federal regulationsEnsures escalation of non-conformance events to the proper operations and corporate QA personnelOversees all quality aspects work in St. Louis, this includes writing, reviewing, and issuing of quality documents, oversight of all projects, review and sign off of all quality records.  Customer Specification ManagementParticipates in the review of new and revised versions of policies and proceduresMonitors compliance to customer specifications and communicates any issues/concernsWorks with operations to resolve any client concerns or complaintsStandardized Operating Procedures (SOP’s)Ensures laboratory personnel have access to the most recent versions of the Corporate Standardized SOP’s and that all training records are currentPrepares laboratory specific versions of SOP’s as directed by the Director of Quality and ComplianceEnsures all forms and work instructions are linked to the laboratory SOP’s and are reviewed, revised, and updated annuallyAuditingLeads internal, customer, corporate, and FDA regulatory audit visitsEngages appropriate operations management to ensure audit responses are completed in the allotted time frame and sustainable corrective actions are identified, agreed to, and implemented within defined time linesCustomer/Consumer ComplaintsManages the laboratory investigation for all complaintsEnsures timely response and a thorough review of all recordsProvides written reports to corporate QA DirectorConducts investigations into incidents and quality issuesDocument findings, performs trend analysis, and communicates to management, employees, and customers as appropriateRecord Review:  Ultimate oversight to ensure all record review is current for laboratory, sanitation, and production documentsFacilitates scheduling and/or delivery of quality/safety training to meet corporate and regulatory requirementsCompletes training as required, to maintain license and certifications required by the positionMaintains current knowledge through seminars and industry publications to develop skills and improve job performanceProtects confidential information and proprietary processes
