Documentation Systems QA Specialist I

Knoa Pharma; Wilson (NC); On-site; USD 65,000 - 85,000; Full time

Job summary

Knoa Pharma is seeking a QA Specialist I, Documentation Systems to support quality systems and regulatory compliance. The role focuses on coordinating global submission documentation, performing routine revisions, issuing and archiving documents, and maintaining FDA/GxP alignment.

Ideal candidates have a Bachelor’s degree with 4+ years in pharmaceutical quality systems, and familiarity with Veeva EDMS and regulatory expectations.

Qualifications

• Bachelor's degree in a relevant field and 4+ years' experience supporting quality systems.
• Experience with GMP/GxP documentation and compliant record-keeping.
• Familiarity with FDA regulations and quality systems tooling such as EDMS.

Responsibilities

• Maintains documentation per internal procedures and regulatory requirements.
• Supports global regulatory submission documentation as required by partners.
• Assists product/process investigations and data analyses for quality management.
• Issues and manages documents, including controlled records and logs.
• Participates in deviation resolution and the document period review process.
• Coordinates with QA and related departments to ensure compliance.
• Communicates improvements and helps close regulatory gaps.
• Supports regulatory inspections when necessary.

Skills

Quality Systems

GxP regulations

Documentation control

Communication

Problem solving

Education

Bachelor's degree

MS preferred

Tools

Veeva EDMS

Job description

Knoa Pharma is seeking a QA Specialist I, Documentation Systems to support quality systems and regulatory compliance. The role focuses on coordinating global submission documentation, performing routine revisions, issuing and archiving documents, and maintaining FDA/GxP alignment.

Ideal candidates have a Bachelor’s degree with 4+ years in pharmaceutical quality systems, and familiarity with Veeva EDMS and regulatory expectations.