Quality Documentation Specialist (GMP/FDA)

Kinetic Personnel Group; Tustin (CA); On-site; USD 25,000 - 28,000; Full time

Job summary

Kinetic Personnel Group is hiring a Quality Assurance Data Entry Clerk to manage essential quality documentation in a regulated GMP environment. You will scan, file, and organize records to ensure quick access during audits and inspections.

The role requires attention to detail, strong organizational skills, and the ability to maintain confidentiality across large document sets. Full-time work with standard day shift in an office/manufacturing setting.

Qualifications

• Required Education: High school diploma or equivalent.
• Preferred Qualifications: Previous experience in document control, records management, quality assurance, or administrative support.
• Experience in GMP, FDA-regulated pharmaceutical/biotech/medical device environment is a plus.

Responsibilities

• Photocopy, scan, and organize quality documents, batch records, and controlled records.
• File quality documentation accurately to ensure immediate retrieval during audits.
• Maintain document organization per company document control procedures.
• Support Quality Document Workflow (QDW), Sample Tracking Workflow (STW), TMF, and BHR archival activities.
• Assist departments with document copying, scanning, filing, and record retrieval.
• Perform routine document audits to verify record completeness and accuracy.
• Maintain confidentiality and integrity of controlled quality documentation.
• Assist with records retention and archival processes.
• Support QA projects and administrative activities as assigned.

Skills

Attention to detail

Organizational skills

Documentation skills

Communication

Teamwork

Accountability

Education

High school diploma or equivalent

Tools

Microsoft Office

Job description

Kinetic Personnel Group is hiring a Quality Assurance Data Entry Clerk to manage essential quality documentation in a regulated GMP environment. You will scan, file, and organize records to ensure quick access during audits and inspections.

The role requires attention to detail, strong organizational skills, and the ability to maintain confidentiality across large document sets. Full-time work with standard day shift in an office/manufacturing setting.