Specialist I, Quality Systems at Werfen

OverviewThe Quality Systems (QS) Specialist I is responsible for assisting in the planning coordination control and continuous improvement of key components of the Quality Management System (QMS) which helps to ensure compliance to GMP requirements FDA & ISO standards and other regulations as they pertain to the QMS.The pay range for this position is currently $33.65-$40.87 hourly. Individual compensation is based on the candidates qualifications for the position including experience skills knowledge education certifications internal equity budget and/or other business and organizational needs.This is a full-time temporary position through June 2026.ResponsibilitiesKey AccountabilitiesThe QS Specialist I will be expected to support some of the activities within the Quality Systems team shown below but will have primary responsibility for at least one of the following:CAPA process tracking trending of approved CAPAs and driving timely/appropriate completion of activities.Deviation process tracking trending and driving timely/appropriate closure.Internal Audit program transfer of any nonconformities issued to the CAPA process and driving timely/appropriate closure.Quality Plans issuing number tracking status appropriate closure.Quality Records scan inventory archive and retrieve quality records; maintain off-site master inventory list.Design Control support the DHF/DCR creation maintenance and archival process; conduct DHF/DCR reviews/audits; act as an independent reviewer during design review.Quality Systems Activities:CAPA.Deviation process.External Document process.Quality Agreements.International QMS compliance with Werfen Affiliates.Quality Plans.Training program.Helps facilitate meetings related to QS activities by taking minutes as directed.Supports change orders/process improvements with respect to Quality Management System procedures with direction from management.Provides support to quality assurance activities for regulatory compliance (i.e. Management Review support Regulatory audits).Assist with development and maintenance of a variety of metrics pertaining to Quality System activities as assigned including data for Management Review and KPIsParticipates in internal external and/or 3rd party audits as needed.Provides support through a general working knowledge of all Werfen Quality System programs.Aids employees based on a clear understanding and implementation of regulatory standards.Carries out duties in compliance with established business policies.Interface with all functions and levels of management as needed.Maintain the accuracy legibility traceability and retrieval of quality documents and records.Other duties as assigned according to the changing needs of the business.QualificationsMinimum Knowledge & Experience required for the position:Bachelors degree (Life Sciences) preferred.Minimum of two (2) years relevant experience or one (1) year related experience with an advanced degree .Previous Quality Assurance experience within a GMP-regulated environment .Skills & Capabilities:Good understanding of record retention.Strong planning organizational and time management skills are .Ability to prioritize urgent matters.Basic understanding of US FDA Quality System Regulations (QSR) is .Basic understanding of ISO 13485:2016 is .Good understanding of Good Manufacturing Practices & Good Documentation Practices.Basic understanding of change control requirements.Computer literacy ; good working knowledge of Microsoft Office programs especially Power-point .Experience with Enterprise Resource Planning (ERP) system (such as SAP) preferred.Technical writing background/experience is a plus.Required Experience:IC Key Skills Quality Assurance,FDA Regulations,Data Collection,Food Safety Experience,ISO 9001,Mobile Devices,Root cause Analysis,Quality Systems,OSHA,Food Processing,Quality Management,cGMP Employment Type : Temp Experience: years Vacancy: 1 Hourly Salary Salary: 33 - 40