Quality & Training Specialist - FDA/ISO CAPA Expert

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Pleasant Prairie (WI)

On-site

USD 65,000 - 90,000

Full time

14 days+
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Benefits offered by this job

Medical Insurance
Dental Insurance
Vision Insurance
Life Insurance
AD&D
Paid Time Off
Employee Assistance Program
Long-Term Disability
Training & Development

Job summary

Arvato is seeking a Training and Quality Specialist to support FDA-regulated processes, CAPA programs, and audit readiness. The role focuses on developing training curricula, delivering sessions, and maintaining documentation across local and international standards.

On-site opportunity in a collaborative environment, requiring strong organizational skills, bilingual capability, and experience with ISO 9001 audits to ensure compliant training practices and continuous improvement across the

Qualifications

  • Understanding of FDA quality system requirements and documentation controls.
  • Experience with CAPA, audits, and quality records.
  • Ability to train, document, and report in a regulated environment.

Responsibilities

  • Review process documents and update training curricula.
  • Train employees and conduct onboarding orientation.
  • Maintain training matrices and evidence of training.
  • Support FDA regulatory documentation and CAPA activities.
  • Administer quality documentation and audit readiness tasks.

Skills

FDA knowledge
MS Office
Training platforms
Communication
Facilitation
Organization
Bilingual
ISO 9001 Internal Auditor
FDA experience

Education

Bachelor’s degree

Tools

MS Office

Job description

Arvato is seeking a Training and Quality Specialist to support FDA-regulated processes, CAPA programs, and audit readiness. The role focuses on developing training curricula, delivering sessions, and maintaining documentation across local and international standards.

On-site opportunity in a collaborative environment, requiring strong organizational skills, bilingual capability, and experience with ISO 9001 audits to ensure compliant training practices and continuous improvement across the

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