Quality Training & Compliance Specialist

Arvato; Pleasant Prairie (WI); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Life insurance

AD&D coverage

Paid time off

Employee assistance

Job summary

Arvato is seeking a dedicated Training & Quality professional to support its FDA-regulated quality systems and training program. The role involves updating training curricula, conducting onboarding sessions, maintaining the training matrix, and coordinating with process owners to ensure ongoing compliance and documentation.

You will drive continuous improvement, participate in audits, and assist in CAPA activities.

Qualifications

• 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.

Responsibilities

• Review process documents and update process Training Curriculum, as needed.
• 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.
• Maintaining knowledge of training and evidence, coordinating with all respective trainers.
• Assist in identifying problems and opportunities, such as operational changes or industry developments that training could improve.
• Assisting in ensuring that training milestones and goals are met.
• Performing other related duties, as assigned by the Quality Supervisor / Manager and required to meet the goals and objectives identified with our training programs
• Supporting the organization of necessary training to increase company qualifications.
• 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.
• 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.
• Supporting 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.
• 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.
• 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, 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.
• Support Quality Controls/ Inspections: monitor calibration activities and quality inspections; ensure controls for FDA-regulated products.

Skills

Excellent written and verbal comms

Highly organized

Facilitate group sessions

MS Office & training tech

Understanding of training/quality

On-site work

Bilingual preferred

ISO 9001 Internal Auditor/FDA exp

Education

Bachelor’s degree

Job description

Arvato is seeking a dedicated Training & Quality professional to support its FDA-regulated quality systems and training program. The role involves updating training curricula, conducting onboarding sessions, maintaining the training matrix, and coordinating with process owners to ensure ongoing compliance and documentation.

You will drive continuous improvement, participate in audits, and assist in CAPA activities.