Quality Training Specialist

Training Overall Responsibilities:Review process documents and update process Training Curriculum, as neededTrain employees on training processesConduct first-day orientation trainingFollow up on yearly training plans and coordinate with respective processesMaintain the training matrix system and reporting tools for trainingMaintaining knowledge of training and evidence, coordinating with all respective trainersAssisting in identifying problems and opportunities, such as operational changes or industry developments that training could improveAssisting in ensuring that training milestones and goals are metPerforming other related duties, as assigned by the Quality  Supervisor / Manager and required to meet the goals and objectives identified with our training programsSupporting the organization of necessary training to increase company qualificationsQuality Overall Responsibilities:Supporting the Introduction of local and international standards into Arvato business processes within the scope of the quality management system. Maintaining working knowledge of applicable FDA quality system and current Good Manufacturing Practice (cGMP) requirements, and applicable FDA expectations related to documentation, records, training, CAPA, complaints, labeling, packaging, storage, and distribution controls.Sharing the necessary information and knowledge regarding Quality Management Systems with relevant internal parties.Supporting FDA-regulated customer requirements by helping ensure procedures, training records, quality records, audit evidence, and corrective action documentation are complete, controlled, traceable, and inspection-ready.Document Management:Conducting documentation studies, revision, record keeping, and archiving.Communication with process owners and working together for updates.Coordinate the creation of sustainable corporate knowledge within the organization.Support FDA documentation expectations by maintaining accurate, legible, controlled, and retrievable records, including training evidence, audit records, CAPA documentation, inspection records, and applicable quality system documents.Audit ManagementSupporting the Quality Supervisor / Manager in internal and external audits (Client, Authority, FDA, Client and Social Audits).Reporting and tracking the findings of the audits together with the Quality Supervisor / Manager.Assist with FDA inspection readiness activities, including preparation of objective evidence, support during regulatory or customer audits, and timely follow-up of findings, observations, and corrective actions.Continuous Improvement: Administer the SharePoint Document and Training Center systems and follow up on related system development issues.Support the implementation of LEAN initiatives, including 5S projects, across the facility.Objectives:Track Training and Quality Department KPIs and objectives.Process and Risk Management: Support organization-wide process and risk-based improvement activities.CAPAs and Claims: Monitor CAPAs and claims, and provide periodic updates to the Quality Supervisor / Manager.Participate in CAPA root cause analysis activities, as needed.Ensure CAPA and claim activities include documented root cause analysis, defined corrective and preventive actions, effectiveness checks, and clear records aligned with ISO and FDA quality system expectations.Quality Controls/ Inspections: Support the Quality Supervisor and Manager with quality control data analysis.Monitor calibration activities and quality inspections.Support applicable controls for FDA-regulated products, including quarantine and release status, traceability, storage conditions, labeling accuracy, packaging controls, and inspection documentation.