Onsite QA/QC Manager — Microbiology & Compliance

United Therapeutics Corporation; Stewartville (MN); On-site; USD 100,000 - 140,000; Full time

Job summary

United Therapeutics Corporation in Stewartville, MN seeks a QA/QC Manager to lead on-site QA/QC microbiology at the DPF facility. You will govern environmental monitoring, oversee deviations and CAPAs, and ensure inspection readiness.

Requires 8+ years in GMP/QSR, a relevant degree, and strong leadership in cGMP environments. You will collaborate with Operations, Animal Care, and Facilities to align microbiology controls with risk and drive continuous improvement.

Qualifications

• 8+ years in GMP/QSR regulated environment
• Experience in environmental monitoring and QC microbiology
• Experience supporting regulatory inspections (FDA, etc.)
• Experience with controlled documents and CAPA systems
• Strong analytical judgment and risk assessment skills

Responsibilities

• Lead QA/QC microbiology operations at the DPF facility
• Govern the environmental monitoring program and trends
• Oversee deviations, CAPA, change controls, and quality records
• Manage audits and supplier qualification activities
• Collaborate with Operations, Facilities, and R&D on quality improvements

Skills

GMP/QSR experience

Environmental monitoring

CAPA management

Root cause analysis

FDA inspections

Data interpretation

Quality leadership

Education

Bachelor’s Degree

Master’s Degree

Tools

MasterControl

TrackWise

Job description

United Therapeutics Corporation in Stewartville, MN seeks a QA/QC Manager to lead on-site QA/QC microbiology at the DPF facility. You will govern environmental monitoring, oversee deviations and CAPAs, and ensure inspection readiness.

Requires 8+ years in GMP/QSR, a relevant degree, and strong leadership in cGMP environments. You will collaborate with Operations, Animal Care, and Facilities to align microbiology controls with risk and drive continuous improvement.