GMP Quality Documentation Specialist

Actalent; Omaha (NE); On-site; USD 30,000 - 39,000; Full time

Benefits offered by this job

Medical, dental, and vision

401(k) Retirement Plan

Paid time off

Onsite lab environment

Job summary

Actalent in Omaha, NE seeks a detail-oriented Quality Documentation Specialist to support GMP-compliant quality systems in a regulated manufacturing environment. You will review raw materials, coordinate lab testing, and maintain quality records to ensure regulatory compliance.

This contract-to-hire role requires strong documentation skills, CAPA knowledge, and experience with FDA/GMP processes. You will work with quality, production, and laboratory teams to drive continuous improvement and

Qualifications

• Experience in QA, QC, or quality documentation.
• Knowledge of CAPA processes and RCA methodologies.
• Strong data entry and documentation skills.
• Familiarity with laboratory processes and testing environments.
• Understanding of FDA regulations, GMP requirements, and audit processes.
• Strong attention to detail and organizational skills.

Responsibilities

• Inspect and approve incoming raw materials for quality.
• Coordinate sampling and testing of raw materials.
• Maintain quality documentation per GMP standards.
• Ensure SOPs and quality policies are followed.
• Coordinate lab testing for materials, environmental monitoring, and finished products.
• Support investigations and CAPA initiatives.
• Participate in root-cause analysis and CAPA.
• Assist internal and external audits and regulatory compliance.
• Collaborate with quality, production, and lab teams to improve quality.

Skills

QA/QC experience

CAPA & RCA

Documentation

GMP/FDA knowledge

Data entry

Lab processes

Attention to detail

Regulatory compliance

Education

Bachelor's in Chemistry/ Biology/ Food Science

Associate's in a scientific field

Job description

Actalent in Omaha, NE seeks a detail-oriented Quality Documentation Specialist to support GMP-compliant quality systems in a regulated manufacturing environment. You will review raw materials, coordinate lab testing, and maintain quality records to ensure regulatory compliance.

This contract-to-hire role requires strong documentation skills, CAPA knowledge, and experience with FDA/GMP processes. You will work with quality, production, and laboratory teams to drive continuous improvement and