What Does A Quality Specialist Do At Thermo Fisher Scientific
* Manage document changes, creations and deletions* Support business/function leaders in the creation, development, implementation and training related to document change.* Support teams throughout document control process to completion as needed.* Update current quality processes as required* Support Quality Management System:* Production approvals: Review and approve batch records, quality control data, Device History Files, for releasing manufactured product for sale.* Audits: Partner with Quality leader to conduct internal audits based on ISO 1345 and FDA CFRA20* Support external and customer audits* Material Management: Incoming material approvals reviewing certificate of performance, quarantine material, reject* Corrective Action Preventative Action: Support CAPA process for correct root cause and effective corrective actions and final approval* Reporting: Key Performance Indicators, Trending Data, Reporting, Metrics based* Partner with Quality leader to ensure
What Does A Quality Specialist Do At World Wide Technology
* Facilitate the Corrective Action/Preventative Action (CAPA) process with cross-functional teams to drive to root cause and corrective actions.* Assist teams with data measurement, analysis, KPI tracking, and actions.* Collect, trend and analyze internal performance metrics. * Promote and influence quality concepts, tools, and processes* Assist in development of procedures, work instructions and other documents.* Collaborate with teams to solve customer/supplier/product issues.* Work independently with cross-functional teams to lead improvement initiatives.* Review current projects and processes to identify and lead improvement opportunities.* Assist in internal audits, as assigned.* Assist with the development of quality systems within new processes, products, and/or services.* Assist with the maintenance of the ISO 9001 and TL 9000 Certificates.* Actively engage with the Continuous Improvement Program (CIP).* Support Safety initiatives and projects, as needed* Develop and maintain collaborative and mutually beneficial relationships with key business partners.* Assist with the writing, validation and control of documentation* Other duties as assigned
What Does A Quality Specialist Do At Kelly Services
* As assigned, works with cross-functional partners and QCO stakeholders to manage and complete internal and external analytics and reporting regarding both medical compliance (GCP, GVP) and healthcare compliance* As assigned, supports QCO colleagues and QCO systems/database management, such as query and issue tracking.* Supports QCO staff in tracking all gRED related significant deviations and corrective action plans as managed in the Roche CAPA system* Supports routine and ad hoc GCP, GVP, and healthcare compliance monitoring of gRED functional compliance processes to help ensure adherence to GCP, GVP, and healthcare compliance policies and SOPs* Supports the collection and review of internal and external audit and inspection data:* Maintains database of all gRED external and internal audit and inspection findings* Responsible for ensuring that all final corrective and preventative action (CAPA) items are received* Documents and conducts routine ad-hoc follow-up to ensure corrective actions or other remedies have been sufficiently completed in a timely manner* Assists in the identification and analysis of potential trends and/or signals across the QMS for gRED ECD* Generate GCP, GVP, and healthcare compliance related metrics and data to drive continuous improvement efforts * Supports and assists the Clinical Science function with QC checking of Trial Master File documents, including protocols, protocol amendments, investigator brochures, informed consent forms, and medical monitoring plans* Supports definition and maintenance of the taxonomy (information architecture) of Early Clinical Development documents and QCO procedural documents* Supports the implementation of technology solutions for knowledge management, including document management and search ensuring they adhere to the taxonomy* Provides regular system administration and maintenance of knowledge management system for controlled documents* Participates in cross-functional teams charged with reviewing, creating, updating and maintaining compliance, and related policies and procedures
What Does A Quality Specialist Do At Raytheon
* Review vendor's inspection data, historical inspection results, technical documentation package, assessment of internal and external documentation which includes inspection criteria and purchase order requirements* Reviews and provides preliminary disposition of nonconforming materials* Partner with Program Quality, Procurement, Logistics, and Engineering to provide a timely resolution and processing of incoming receipts including material non-conformances* Participates on teams and initiatives focused on the root cause analysis and systemic elimination of Supplier non-conformances by addressing root cause and corrective action* Provides support in RIT metric reporting and data management* Participates in updating and maintenance of documented procedures* Participate in generating and management of Supplier Corrective Action Requests (SCAR)* Participate on teams and initiatives focused on identifying and eliminating internal processes'limitations and inefficiencies
What Does A Quality Specialist Do At Taylor Corporation
* Review customer supplied engineering drawings and/or internal proofs to production material/capabilities and document/request customer approved deviations as needed.* Coordinate all customer required PPAP / FAIR requirements.* Act as primary liaison for supplier training and conformance.* Review all PPAP’s/FAIR’s prior to submission to customer.* Serve as primary customer and supplier point of contact for submission, approval/rejection, and formal record retention, ensuring CCA is engaged and updated throughout the process.* Ensure suppliers and internal plants are in compliance with all Customer quality requirements.* Coordinate all aspects of issue resolution and corrective action activity (8D, A3, eCAR) with suppliers* Support CCA’s by participating in customer discussions as needed.* Serves as department SME for regulatory affairs – UL/CSA, RoHS, Conflict Minerals, etc.* Communicate effectively with Customer Service Leadership team, informing them regularly of all eCAR/error activity via weekly Report outs* Assist CS Manager in the review and processing of all eCAR’s assigned to Labels Customer Service team* Conduct deep dives on repetitive issues and lead corrective action implementation/audit.* Would provide direct quality support to Dayton In* Mold Label plant (first article inspections, problem solving and quality reporting)* Lead process standardization, documentation, employee training, and auditing of key initiatives as identified by Customer Service Management team.* Works with Corporate QA to drive suppler continuous improvement initiatives (i.e. ISO, Lean or Six Sigma).* Partner with Corporate QA and Strategic Sourcing in various aspects of supplier quality management including supplier audits, compliance assessment, performance management/metrics, and other areas as needed
