Quality Training Specialist

Bertelsmann-Jobs • Pleasant Prairie, WI

23d • Onsite

About The Position

Arvato is seeking a Quality Training Specialist to join their team. This role involves supporting the development and delivery of training programs, ensuring compliance with quality standards, and managing documentation related to quality and training processes. The specialist will work within a collaborative environment focused on logistics excellence and supply chain management, particularly within industries such as Consumer Products, Tech, Healthcare, Automotive, and Publishers. The position requires a strong understanding of quality management systems, particularly those related to FDA regulations and ISO standards.

Requirements

• Knowledge of FDA quality system requirements, including document control, training records, audit readiness, CAPA, complaint handling, and quality record retention.
• Proficient in Microsoft Office programs and training technology platforms.
• Excellent written and verbal communication skills.
• Understanding of training and quality processes, including program development.
• Ability to facilitate moderate to large group sessions.
• Highly organized and detail-oriented, with the ability to independently manage projects and programs.
• Working on-site

Nice To Haves

• Bachelor’s degree strongly preferred
• Bilingual strongly preferred
• Preferred ISO 9001:2015 Internal Auditor certification and FDA experience.

Responsibilities

• Review process documents and update training curriculum.
• Train employees on training processes.
• Conduct first-day orientation training.
• Follow up on yearly training plans and coordinate with respective processes.
• Maintain the training matrix system and reporting tools for training.
• Maintain knowledge of training and evidence, coordinating with all respective trainers.
• Assist in identifying problems and opportunities that training could improve.
• Assist in ensuring that training milestones and goals are met.
• Perform other related duties as assigned by the Quality Supervisor/Manager.
• Support the organization of necessary training to increase company qualifications.
• Support the introduction of local and international standards into Arvato business processes.
• Maintain working knowledge of applicable FDA quality system and current Good Manufacturing Practice (cGMP) requirements.
• Share necessary information and knowledge regarding Quality Management Systems with relevant internal parties.
• Support 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.
• Conduct documentation studies, revision, record keeping, and archiving.
• Communicate with process owners and work 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.
• Support the Quality Supervisor/Manager in internal and external audits.
• Report and track the findings of the audits together with the Quality Supervisor/Manager.
• Assist with FDA inspection readiness activities.
• Administer the SharePoint Document and Training Center systems.
• Support the implementation of LEAN initiatives, including 5S projects, across the facility.
• Track Training and Quality Department KPIs and objectives.
• Support organization-wide process and risk-based improvement activities.
• Monitor CAPAs and claims, and provide periodic updates to the Quality Supervisor/Manager.
• Participate in CAPA root cause analysis activities.
• Ensure CAPA and claim activities include documented root cause analysis, defined corrective and preventive actions, effectiveness checks, and clear records.
• 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.

Benefits

• Company paid Medical, Dental, Vision, Life Insurance, and Accidental Death & Dismemberment Benefits.
• Non-taxable Long-Term Disability benefits.
• Paid Time Off, including paid holidays.
• Employee Assistance Program.
• Ongoing employee development training.
• Employee engagement activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level