QA Auditor – Production

Hubot | Tri Pac, Inc. CDMO; South Bend (IN); On-site; USD 42,000 - 58,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company contribution

Paid time off and holidays

Job summary

Hubot, Inc. in Indiana is seeking a QA Auditor – Production to be the quality presence on the manufacturing floor. You will ensure lines and finished products meet specifications and help identify nonconforming product.

You will partner with Manufacturing, Quality Control, Engineering, and Validation to ensure GMP compliance and proper documentation; strong attention to detail and hands-on QA experience are essential.

Qualifications

• High school diploma or GED (associate’s degree or technical certificate a plus).
• 2–3+ years of hands-on experience with quality checks or quality systems in a manufacturing setting.
• Strong math and problem-solving skills.
• Proficiency in Microsoft Word and Excel.
• Strong attention to detail and the ability to follow detailed written instructions.
• Clear verbal and written communication.
• A safety-first mindset and commitment to following strict procedures.

Responsibilities

• Monitor production line parameters and performance for adherence to SOPs, quality guidelines and facility procedures.
• Perform in-process and finished product inspections and physical tests against quality specifications.
• Pull, label and track product samples for the internal lab, retain storage and external clients.
• Identify, document and place nonconforming product on hold; escalate issues to production and QA leadership.
• Take part in root cause analysis and support corrective actions (CAPA).
• Verify instrument and gauge calibration status before use.
• Complete all quality records accurately and in real time, following good documentation practices (GDP).
• Keep inspection areas and lab spaces clean, organized and audit-ready.
• Other duties as assigned.

Skills

Quality checks

Manufacturing quality systems

Attention to detail

Verbal and written communication

Math and problem solving

Microsoft Word

Microsoft Excel

ASQ certification (CQI/CQT)

Education

High school diploma or GED

Tools

Measuring tools (calipers, gauges)

Job description

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.

This position is not eligible for visa sponsorship.

About the role

As a QA Auditor – Production, you’ll be Quality’s presence on the manufacturing floor. You’ll check that production lines and finished products meet specifications, catch and hold nonconforming product, and help find the root cause when something goes wrong.Ths role erves as a quality representative on the manufacturing floor, providing quality oversight for production activities, batch documentation review, deviation management, and GMP compliance. This role partners closely with Manufacturing, Quality Control, Engineering, and Validation teams to ensure products are manufactured according to approved procedures and regulatory requirements.

What you’ll do

• Monitor production line parameters and performance for adherence to SOPs, quality guidelines and facility procedures
• Perform in-process and finished product inspections and physical tests against quality specifications
• Pull, label and track product samples for the internal lab, retain storage and external clients
• Identify, document and place nonconforming product on hold; escal… issues to production and QA leadership
• Take part in root cause analysis and support corrective actions (CAPA)
• Verify instrument and gauge calibration status before use
• Complete all quality records accurately and in real time, following good documentation practices (GDP)
• Keep inspection areas and lab spaces clean, organized and audit-ready
• Other duties as assigned

What you bring

• High school diploma or GED (associate’s degree or technical certificate a plus)
• 2–3+ years of hands‑on experience with quality checks or quality systems in a manufacturing setting
• Strong math and problem‑solving skills
• Proficiency in Microsoft Word and Excel
• Strong attention to detail and the ability to follow detailed written instructions
• Clear verbal and written communication
• A safety‑first mindset and commitment to following strict procedures

Nice to have

• Experience in a GMP or regulated industry (pharma, medical device, food or cosmetics)
• Experience with measuring tools (calipers, scales, gauges) or basic lab testing
• ASQ certification (e.g., CQI, CQT)

Physical requirements

• Able to lift at least 30 lbs
• Able to climb stairs and ladders
• Able to gown and work in cleanroom and lab environments
• Flexible to work 8–10 hour shifts

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 / Aff… All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status