QA Auditor – Production | GMP Quality on the Line

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. 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.