Quality Training Specialist

Arvato • Pleasant-Prairie, WI

22d • Onsite

About The Position

Arvato is a leading global 3PL service provider in supply chain management and e-commerce. This role is responsible for training employees on processes, maintaining training records, and supporting the implementation of quality standards and FDA regulations. The specialist will assist in ensuring procedures, training records, and quality records are complete, controlled, traceable, and inspection-ready. They will also support internal and external audits, manage document control systems, and contribute to continuous improvement initiatives.

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.

Nice To Haves

• Bachelor’s degree strongly preferred.
• Bilingual strongly 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.
• Assist with FDA inspection readiness activities.
• Administer the SharePoint Document and Training Center systems.
• Support the implementation of LEAN initiatives.
• 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.
• Participate in CAPA root cause analysis activities.
• Support the Quality Supervisor and Manager with quality control data analysis.
• Monitor calibration activities and quality inspections.
• Support applicable controls for FDA-regulated products.

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