GMP QA Floor Operations Specialist

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

Job summary

Bio-Techne Singapore is seeking an QA Operations Specialist - Floor Support to provide QA oversight for on-the-floor manufacturing and visual inspection in a GMP facility. You will review batch records, perform line clearances, and discharge disposition of raw materials, with cross-functional collaboration to resolve issues.

The role emphasizes real-time QA monitoring of processes, adherence to regulatory standards, and support for phase-appropriate GMP manufacturing of clinical and commercial

Qualifications

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

Responsibilities

• Provide on-the-floor QA support for manufacturing, including room release and GMP documentation review.
• Collaborate with Operations, QC, Facilities/Engineering, Project Management, and Materials Management to resolve complex issues.
• Conduct frequent walkthroughs and audits of manufacturing and support areas to ensure policy adherence.
• Review batch records for compliance with internal procedures and Good Documentation Practices.

Skills

Attention to detail

Verbal and written communication

Multitasking in a fast-paced env.

Regulatory knowledge (FDA/ICH)

RCA / problem solving

Education

Bachelor's degree in a relevant scientific field

ASQ certification (preferred)

Tools

Microsoft Word

Microsoft Excel

Microsoft AX

Job description

Bio-Techne Singapore is seeking an QA Operations Specialist - Floor Support to provide QA oversight for on-the-floor manufacturing and visual inspection in a GMP facility. You will review batch records, perform line clearances, and discharge disposition of raw materials, with cross-functional collaboration to resolve issues.

The role emphasizes real-time QA monitoring of processes, adherence to regulatory standards, and support for phase-appropriate GMP manufacturing of clinical and commercial