Job Information
Aerotek Document Review Operator - 2nd Shift in Irvine, California
Job Title: Document Review Operator - 2nd Shift Job Description
Join our team as a Document Review Operator, where you will play a critical role in ensuring the accuracy and compliance of manufacturing documentation. You will be responsible for reviewing and verifying a range of documents, facilitating timely corrections, and maintaining high standards of quality control.
Responsibilities
Review manufacturing work orders, travelers, and lot history records for completeness, correctness, and GDP compliance.
Reconcile subassembly and top-level work orders for accuracy, ensuring quantities, yields, rejects, and process calculations match supporting records.
Verify the presence and completion of required attachments, such as inspection records and equipment logs.
Perform in-process documentation checks to identify and correct issues early, communicating findings to operators and Team Leads.
Identify and coordinate timely corrections for documentation irregularities, escalating issues as per procedure.
Ensure documentation-related deviations/nonconformances are properly initiated, referenced, and routed.
Maintain review turn-around times aligned to production schedules and quality requirements.
Track and trend documentation errors, providing feedback and proposing improvements using Lean tools.
Support document retrieval for audits, investigations, complaints, CAPA, and continuous improvement activities.
Follow all safety, cleanroom, and gowning requirements.
Essential Skills
2+ years of experience in a regulated manufacturing environment, preferably in medical device manufacturing.
Experience in reviewing or completing manufacturing documentation in compliance with GDP/GMP expectations.
Proficiency in Microsoft Office and experience with ERP/MES/eQMS systems.
Strong attention to detail and ability to perform basic math checks.
Ability to communicate issues clearly and professionally.
Additional Skills & Qualifications
High school diploma/GED required.
Working knowledge of ISO and regulated quality systems.
Exposure to EU MDR requirements and/or FDA 21 CFR Part 820 requirements preferred.
Experience supporting audits/inspections and maintaining audit-ready documentation.
Lean manufacturing knowledge and understanding of ALCOA+ data integrity expectations.
Why Work Here?
Join a dynamic team with opportunities for growth as we work towards FDA approval this year. Be part of an innovative environment where your contributions are valued and recognized.
Work Environment
Work in a cleanroom environment with a focus on quality and compliance. Enjoy two 30-minute breaks, including one on-the-clock break, while upholding safety and cleanroom standards.
Job Type & Location
This is a Contract to Hire position based out of Irvine, CA.
Pay and Benefits
The pay range for this position is $24.00 - $24.00/hr.
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 Irvine,CA.
Application Deadline
This position is anticipated to close on Mar 20, 2026.
About Aerotek:
We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meets their goals, skills and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role solving for companies’ construction, manufacturing and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are everything spirit to the test as your career continues to grow.
Aerotek offers weekly pay, employee benefits including medical, dental & vision, life insurance, health advocacy and employee assistance programs, a 401(k) plan, and employee discounts.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.