GMP-Lean Manufacturing Supervisor — Quality & Ops

Nuclein, LLC; Austin (TX); On-site; USD 70,000 - 100,000; Full time

Job summary

Nuclein, LLC is seeking a Manufacturing Supervisor to oversee daily production, ensure compliance with FDA regulations and GMP guidelines, and drive continuous improvement for quality and efficiency. The role involves leading the assembly team, coordinating training, and collaborating with QA/QC to resolve issues in a fast-paced environment.

The ideal candidate has 5+ years in manufacturing operations, an associate degree (bachelor’s preferred), and experience with ERP systems and MS Office.

Qualifications

• Associate degree required; bachelor’s degree preferred.
• 5+ years in manufacturing operations, preferably in medical device.
• Experience with FDA regulations and GMP guidelines.
• Strong problem-solving and decision-making skills.
• Experience operating ERP systems.

Responsibilities

• Oversee day-to-day manufacturing activities and resources.
• Ensure cGMP processes and procedures are followed.
• Monitor production metrics and drive corrective actions.
• Ensure FDA and GMP compliance through audits.
• Coordinate training documentation for assembly staff.
• Collaborate with QA/QC to address quality issues.
• Lead continuous improvement and lean manufacturing efforts.
• Supervise assembly personnel and participate in hiring.
• Promote safety and conduct incident investigations.
• Monitor department costs and escalate concerns.

Skills

Leadership

Problem solving

Communication

Cross-functional teamwork

Education

Associate's degree

Bachelor's degree preferred

Tools

ERP systems

Microsoft Office

Job description

Nuclein, LLC is seeking a Manufacturing Supervisor to oversee daily production, ensure compliance with FDA regulations and GMP guidelines, and drive continuous improvement for quality and efficiency. The role involves leading the assembly team, coordinating training, and collaborating with QA/QC to resolve issues in a fast-paced environment.

The ideal candidate has 5+ years in manufacturing operations, an associate degree (bachelor’s preferred), and experience with ERP systems and MS Office.