GMP Floor QA Specialist – Manufacturing & Compliance

Research & Diagnostic Systems, Inc.; Saint Paul (MN); On-site; USD 56,000 - 91,000; Full time

Job summary

Bio-Techne is seeking an QA Operations Specialist - Floor Support to provide on-the-floor QA oversight of manufacturing and visual inspection in a GMP setting. You will review batch records, approve deviations, and ensure cGMP compliance while supporting continuous quality improvements.

Ideal candidates have a Bachelor’s in a scientific field, 3+ years in GMP with QA exposure, and familiarity with RCA, documentation practices, and regulatory standards.

Qualifications

• Required: Bachelor's degree in a relevant scientific field.
• Minimum 3 years’ experience in GMP industry, with at least 1 year in Quality.
• ASQ certification is a plus.
• Exposure to RCA, technical writing, and quality investigations.

Responsibilities

• Perform QA on-the-floor activities supporting projects, including room release and GMP document reviews.
• Consult with Operations, QC, Facilities/Engineering, Project Management, and Materials Management to resolve issues.
• Conduct walkthroughs and internal audits of manufacturing and support areas to ensure policy adherence.
• Oversee batch record review for compliance with procedures and GD&Ps.
• Review and disposition incoming materials and finished product stock as needed.
• Assist in quality systems such as deviations, CAPA, and nonconformances.

Skills

GMP experience

Quality assurance

Root cause analysis

Documentation practices

Communication skills

Auditing

Education

Bachelor's degree in a relevant scientific field

Tools

FMEA

HACCP

ICH Q9

Job description

Bio-Techne is seeking an QA Operations Specialist - Floor Support to provide on-the-floor QA oversight of manufacturing and visual inspection in a GMP setting. You will review batch records, approve deviations, and ensure cGMP compliance while supporting continuous quality improvements.

Ideal candidates have a Bachelor’s in a scientific field, 3+ years in GMP with QA exposure, and familiarity with RCA, documentation practices, and regulatory standards.