Senior Quality Documentation Specialist

Integer Holdings; Plymouth (MN); On-site; USD 34,000 - 50,000; Full time

Benefits offered by this job

Medical insurance

Dental and vision benefits

401(k) with company match

Paid time off

Job summary

Integer Holdings is seeking a documentation administrator to support the Quality function in GMP-compliant records management. You will handle controlled documents, change records, and access control while ensuring GDP practices are followed.

Responsibilities include audits support, cross-functional guidance, training, and maintaining documents in line with QMS and FDA requirements. This role emphasizes accuracy, organization, and collaboration across departments.

Qualifications

• Minimum Education: Diploma / or equivalent in administration preferred.
• Minimum Experience: 4+ years of experience. Expertise developed through on the job training and job experience.

Responsibilities

• Adhere to company policies and procedures and all safety and quality requirements including QMS, EMS, FDA regulations and other regulatory requirements as required in your location.
• Provide administrator support for change record implementation in line with standard operating procedures.
• Control distribution and retrieval of documents including electronic files of controlled documents.
• Notify applicable functions when local external documents change (as required).
• Manage and control access to on-site and off-site records and documents.
• Perform annual record disposition review.
• Compile / complete quality records, reports and / or documentation ensuring GDP applied.
• Review DHR per applicable procedures and GDP.
• Assist the Quality department during audits.
• Provide support / guidance and analysis to other departments.
• Train personnel in proper techniques to utilize systems, and processes.
• Performs other duties as required.

Skills

Leadership

Effective communication

Organizational skills

MS Teams

Excel

Attention to detail

Problem solving

Education

Diploma / or equivalent in administration

Job description

Integer Holdings is seeking a documentation administrator to support the Quality function in GMP-compliant records management. You will handle controlled documents, change records, and access control while ensuring GDP practices are followed.

Responsibilities include audits support, cross-functional guidance, training, and maintaining documents in line with QMS and FDA requirements. This role emphasizes accuracy, organization, and collaboration across departments.