Quality Specialist I (Pharmaceutical Manufacturing)

Location: Irvine, California, United States; onsite

Salary: $90,000–$107,000 annually

Company

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

What you will do

• Review SOPs, protocols, reports, batch records, and other documentation supporting manufacturing and product release.
• Evaluate data and metadata for accuracy, completeness, and integrity.
• Support deviation investigations, CAPAs, and related report reviews.
• Ensure compliance with FDA, ICH, GMP, and internal quality requirements.
• Provide oversight for equipment and software qualification, validation, and calibration.
• Partner with quality and cross-functional teams to maintain compliant, standardized processes.

Requirements

• Bachelor’s degree or equivalent experience in a related field.
• At least 4 years of experience in quality, manufacturing, or a regulated environment.
• Understanding of GMP and regulatory requirements and data integrity principles.
• Strong attention to detail and problem-solving skills.
• Ability to work independently and manage priorities.
• Ability to work onsite in Irvine, California, with some time in a manufacturing environment.

Culture & Benefits

• Healthcare benefits.
• 401(k) plan.
• Tuition reimbursement.
• Work in an environment focused on patient, clinician, and environmental safety.
• Participation in a global knowledge-sharing and continuous-improvement culture.