GMP/FDA Quality & Training Specialist

Arvato; Pleasant Prairie (WI); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

Paid Time Off

Employee Assistance Program

Disability Benefits

Job summary

Arvato is seeking a dedicated Training and Quality Programs specialist to support FDA documentation, CAPA, and quality system records at our Wisconsin facility. The role emphasizes process improvement, training oversight, and readiness for internal and external audits.

The ideal candidate will have a Bachelor’s degree (preferred), strong Microsoft Office skills, and experience with training development, documentation controls, and regulatory requirements.

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

• 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 Management: Supporting audits and providing follow-up of findings, including FDA and client inspections.

Skills

FDA quality systems

Microsoft Office

communication skills

training processes

facilitation

organization

on-site work

bilingual (preferred)

ISO 9001 Internal Auditor (preferred)

FDA experience (preferred)

Education

Bachelor's degree preferred

Tools

Microsoft Office

Job description

Arvato is seeking a dedicated Training and Quality Programs specialist to support FDA documentation, CAPA, and quality system records at our Wisconsin facility. The role emphasizes process improvement, training oversight, and readiness for internal and external audits.

The ideal candidate will have a Bachelor’s degree (preferred), strong Microsoft Office skills, and experience with training development, documentation controls, and regulatory requirements.