GMP QA Operations Specialist — On‑the‑Floor Impact

Bio-Techne; Saint Paul (MN); On-site; USD 56,000 - 91,000; Full time

Job summary

Bio-Techne in Saint Paul, MN is seeking a QA Operations Specialist – Floor Support to provide on-the-floor QA oversight of manufacturing and aseptic processes in a GMP facility. The role requires real-time review of batch records, deviation handling, CAPA initiation, and collaboration with Operations, QC, Facilities, and Materials Management.

On-site work with a strong emphasis on compliance and continuous improvement.

Qualifications

• Bachelor’s degree in a relevant scientific field.
• Minimum 3 years’ experience in relevant GMP industry, with minimum 1 year experience in Quality.
• ASQ certification is a plus.
• Exposure to RCA, technical writing, and working with quality-related investigations

Responsibilities

• QA on-floor activities supporting projects, including room release and auditing critical processes.
• Review GMP documentation in real time and resolve issues.
• Batch record review and disposition of materials.
• Support deviations, CAPA, and nonconformances; participate in audits and investigations.

Skills

QA on-floor oversight

Root cause analysis

Technical writing

Quality investigations

Cross-functional collaboration

Project management

Attention to detail

Communication skills

Education

Bachelor’s degree in a relevant scientific field

Tools

Microsoft Word

Microsoft Excel

Job description

Bio-Techne in Saint Paul, MN is seeking a QA Operations Specialist – Floor Support to provide on-the-floor QA oversight of manufacturing and aseptic processes in a GMP facility. The role requires real-time review of batch records, deviation handling, CAPA initiation, and collaboration with Operations, QC, Facilities, and Materials Management.

On-site work with a strong emphasis on compliance and continuous improvement.