Quality Documentation Specialist

Actalent

Omaha (NE)

On-site

USD 30,000 - 39,000

Full time

12 days ago
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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

Overview

We are seeking a detail-oriented Quality Documentation Specialist to support quality assurance activities within a regulated manufacturing environment. This role is responsible for reviewing and approving raw materials, coordinating laboratory testing, maintaining quality documentation, and ensuring compliance with GMP, FDA, and internal quality standards.

The ideal candidate will have experience in quality systems, laboratory processes, and regulatory documentation, along with a strong commitment to accuracy and continuous improvement.

What You'll Do
  • Inspect and approve incoming raw materials to ensure compliance with quality standards.
  • Coordinate and perform raw material sampling and testing activities.
  • Maintain accurate quality documentation and records in accordance with GMP requirements.
  • Ensure compliance with Standard Operating Procedures (SOPs) and quality policies.
  • Coordinate laboratory testing for raw materials, environmental monitoring, food-contact surfaces, and finished products.
  • Support investigations, corrective actions, and continuous improvement initiatives.
  • Participate in root cause analysis and CAPA activities to address quality concerns.
  • Assist with internal and external audits and regulatory compliance efforts.
  • Collaborate with quality, production, and laboratory teams to drive product quality and process improvements.
QualificationsRequired
  • Experience in Quality Assurance, Quality Control, or Quality Documentation.
  • Knowledge of CAPA processes and Root Cause Analysis 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.
Preferred
  • Bachelor's degree in Chemistry, Biology, Food Science, Microbiology, or a related scientific field with 1+ year of GMP experience.
  • OR Associate's degree in a scientific discipline with 3+ years of quality documentation experience in a GMP-regulated environment.
  • Experience working in food, pharmaceutical, biotech, or other regulated manufacturing industries.
Work Environment
  • Monday-Friday schedule, 7:30 AM to 4:00 PM.
  • Minimal overtime required.
  • Laboratory and quality-focused work environment.
  • Strong emphasis on regulatory compliance, documentation accuracy, and product quality.
  • Collaborative team setting with interaction across quality, laboratory, and production departments.
Why Join Us?
  • Stable weekday schedule with excellent work-life balance.
  • Opportunity to work in a highly regulated and quality-driven environment.
  • Exposure to laboratory operations, compliance programs, and continuous improvement initiatives.
  • Collaborative culture focused on quality, safety, and professional growth.
  • Opportunity to make a direct impact on product quality and regulatory compliance.

This is an excellent opportunity for a quality professional with GMP experience who enjoys documentation, compliance, and working closely with laboratory and manufacturing teams to maintain the highest quality standards.

Job Type & Location

This is a Contract to Hire position based out of Omaha, NE.

Pay and Benefits

The pay range for this position is $22.00 - $28.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Omaha,NE.

Application Deadline

This position is anticipated to close on Oct 5, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

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