Quality Assurance Auditor

Hubot | Tri Pac, Inc. CDMO; South Bend (IN); On-site; USD 45,000 - 65,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company contribution

Paid time off

Job summary

Hubot, Inc. is seeking a Quality Assurance Auditor to perform quality checks per specifications, identify non-conforming products, and conduct root cause analysis in a FDA-regulated lab setting.

The role involves reviewing production parameters, testing samples, and maintaining lab safety and organization. Ideal candidates have 2–3+ years of hands-on QA experience, strong math skills, and excellent communication.

Qualifications

• 2–3+ years hands-on experience with quality systems and checks.
• Education: High School or higher; strong math and problem solving preferred.

Responsibilities

• Review production line parameters and performance for adherence to SOPs, quality guidelines, and facility procedures.
• Test samples for physical adherence to finished product quality specifications.
• Pull and identify product samples for internal lab, retain, and external customers.
• Maintain work area cleanliness and organization.
• Follow detailed instructions; work 8–10 hour days; lift up to 30 lbs; climb stairs/ladder.
• Work in a cleanroom environment and lab; communicate clearly.

Skills

Quality systems

Root cause analysis

Attention to detail

Communication skills

Safety practices

Education

High School Diploma

Mathematics skills

Job description

This position is not eligible for visa sponsorship.

About Hubot

Hubot, Inc. is an FDA-registered contract development and manufacturing organization (CDMO) specializing in liquids, semi solids and aerosol filling for global pharmaceutical and personal care brands including Fortune 500 clients. We develop and manufacture products that reach consumers across the world, and our analytical laboratory is central to making that happen safely, accurately, and on time.

Why Hubot ?

Growth-Stage Opportunity We're forecasting 25–30% year-over-year revenue growth through 2030. This is a rare chance to join a scaling CDMO where your contributions directly shape laboratory capabilities not just maintain them.

Real Client Impact You'll work on products that ship to Fortune 500 pharmaceutical and personal care brands. Your analytical work isn't academic it releases product, supports regulatory submissions, and protects patients and consumers.

Regulated Industry Depth Our laboratory operates under FDA 21 CFR 210/211, ISO 13485, ISO 9001, ISO 14001 and ISO 22716 cGMP standards. You'll sharpen expertise in frameworks that are valued across the global pharmaceutical and personal care supply chain.

Job Description

The Quality Assurance Auditor will perform quality control checks per specifications, identify non-conforming products and perform root cause analysis.

Responsibilities

• Review of production line parameters and performance for adherence to Company Standard Operating Procedures, Quality Guidelines and Facility Procedures
• Testing samples for physical adherence to Quality Specifications for Finished Product
• Pull and identify product samples for the internal lab, retain, and external customers
• Responsible for work area cleanliness and organization
• Ability to follow detailed instructions
• Must be flexible to work 8-10 hour days
• Able to lift a minimum of 30 lbs
• Ability to climb stairs/ladder
• Ability to work in a Cleanroom environment and lab
• Must have good communication skills, both verbal and written
• Able to work safely, carefully and follow strict guidelines
• Detail oriented
• Other duties as assigned

Education And/or Experience

• Education: High School or higher, excellent mathematics and problems solving skills preferred
• 2-3 + years hands-on experience with quality systems and checks

What We Offer

• Competitive base salary commensurate with experience
• Medical, dental, and vision insurance
• 401(k) with company contribution
• Paid time off and holidays

Hubot, Inc. is an Equal Employment Opportunity / Affirhmtive Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status