QA Associate I, Sterilization Assurance

Location: Onsite in Irvine, California, United States. Regular and predictable onsite attendance is required; relocation is not available.

Salary: $24.00–$28.00 per hour

Company

hirify.global develops and manufactures medical products and services for healthcare, including infusion therapy, pain management, nutrition, pharmacy compounding, wound care, and dialysis.

What you will do

• Review sterilization records, batch documentation, and quality system records for accuracy, completeness, and compliance.
• Use LIMS, MES, Wonderware, and Electronic Batch Records to support sterilization review and product release.
• Identify, document, and escalate deviations, nonconformances, and documentation discrepancies.
• Verify sterilization documentation and traceability records for product disposition and release decisions.
• Collaborate with Manufacturing, Quality, Engineering, and Facilities to resolve quality issues.
• Support continuous improvement initiatives and maintain audit-ready records.

Requirements

• High school diploma or GED.
• At least one year of experience in manufacturing, quality, laboratory, or FDA-regulated environments.
• Experience reviewing documentation for accuracy, completeness, and compliance.
• Working knowledge of GMPs, GDP, quality systems, and data integrity requirements.
• Proficiency with Microsoft Office and electronic quality systems, with strong organizational, analytical, and problem-solving skills.
• Ability to work onsite in Irvine and work non-standard hours as business needs require.

Nice to have

• Associate or bachelor's degree in biology, microbiology, chemistry, biomedical sciences, engineering, quality management, or a related scientific discipline.
• Experience in pharmaceutical, medical device, biotechnology, or other regulated manufacturing environments.
• Familiarity with sterilization processes, validation, CAPA, deviation investigations, and nonconformance management.
• Experience with LIMS, MES, Wonderware, Electronic Batch Records, or similar systems.
• Knowledge of FDA regulations, including 21 CFR Part 11 and cGMP requirements.

Culture & Benefits

• Work across office, laboratory, and GMP-regulated manufacturing environments.
• Collaborate with cross-functional Manufacturing, Quality, Engineering, and Facilities teams.
• Healthcare benefits and a 401(k) plan.
• Tuition reimbursement.
• Focus on quality, compliance, safety, and continuous improvement.