QA Technician Assistant II - GMP/QA, 1st Shift

Siegfried; Irvine, Northern (CA, KY); Hybrid; USD 37,000 - 44,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life Voluntary Accident

Hospital

Pet 401K

Generous Time Off Structure

Job summary

Siegfried is seeking a Quality Assurance Technician to join its FDA-regulated manufacturing operations in Irvine, CA. The role focuses on ensuring products are manufactured safely, complying with cGMP, and supporting documentation and QA inspections on the production floor.

You will perform line clearances, in-process inspections, and batch record reviews, while coordinating with Manufacturing and Quality teams.

Qualifications

• 1-2 years of experience in pharmaceuticals, medical devices, or another FDA-regulated industry.
• Previous QA experience preferred.
• Strong attention to detail and commitment to quality.
• Solid computer, documentation, and communication skills.
• High School Diploma or GED required; college coursework or technical training preferred.

Responsibilities

• Provide on-the-floor QA support for pharmaceutical manufacturing operations.
• Perform line clearances, in-process inspections, and quality checks.
• Review batch records and manufacturing documentation for accuracy and compliance.
• Prepare samples for Quality Control testing.
• Support deviation investigations and GMP event documentation.
• Utilize quality systems including SAP, LIMS, and TrackWise.
• Help maintain a state of compliance with cGMP and regulatory requirements.

Skills

Quality Assurance

GMP

FDA regulations

Documentation

Education

High School Diploma or GED

Tools

SAP

LIMS

TrackWise

Job description

Siegfried is seeking a Quality Assurance Technician to join its FDA-regulated manufacturing operations in Irvine, CA. The role focuses on ensuring products are manufactured safely, complying with cGMP, and supporting documentation and QA inspections on the production floor.

You will perform line clearances, in-process inspections, and batch record reviews, while coordinating with Manufacturing and Quality teams.