GMP Documentation Specialist

Integer Holdings Corporation; Plymouth (MN); Sur place; USD 28 000 - 41 000; Plein temps

Avantages offerts par ce poste

Health benefits

Dental/Vision coverage

Disability insurance

Life insurance

Adoption benefits

401(k) with company match

Parental leave

Paid time off

Paid holidays

Résumé du poste

Integer Holdings Corporation is seeking a documentation administrator to support GMP-compliant documentation control and quality system workflows. You will process change records, manage controlled documents, and ensure GDP best practices across the site.

The role emphasizes cross-functional collaboration, training, and adherence to regulatory requirements, with a strong focus on quality metrics and continuous improvement.

Qualifications

• 4+ years of experience in administration or related role.
• Diploma or equivalent in administration.
• Familiarity with GMP/quality systems desirable.
• Strong written and verbal communication.

Responsabilités

• Adhere to company policies and procedures and all safety and quality requirements including QMS and FDA regulations.
• Provide administrator support for change record implementation per SOPs.
• Control distribution and retrieval of documents including electronic files of controlled documents.
• Notify applicable functions when local external documents change.
• Manage access to on-site and off-site records and documents.
• Perform annual record disposition review.
• Compile quality records, reports and documentation with GDP.
• Review Device History Record per procedures and GDP.
• Assist the Quality department during audits.
• Provide support to other departments and train personnel on systems and processes.

Connaissances

Leadership

Effective communication

Organizational skills

General computer skills

Attention to detail

Problem solving

Formation

Diploma / or equivalent in administration

Description du poste

Integer Holdings Corporation is seeking a documentation administrator to support GMP-compliant documentation control and quality system workflows. You will process change records, manage controlled documents, and ensure GDP best practices across the site.

The role emphasizes cross-functional collaboration, training, and adherence to regulatory requirements, with a strong focus on quality metrics and continuous improvement.