Onsite QA/QC Leader — Microbiology & Compliance

United Therapeutics Corporation; Houston (TX); Vor Ort; USD 125.000 - 180.000; Vollzeit

Benefits dieser Stelle

Medical/Dental/Vision benefits

401k & ESPP

Paid time off

Zusammenfassung

United Therapeutics Corporation seeks an experienced QA/QC Manager to lead on-site QA/QC microbiology and environmental monitoring at the Designated Pathogen-Free facility in Houston, TX. You will drive deviation and CAPA programs, ensure inspection readiness, and align QC with operations.

You will oversee MasterControl and TrackWise documentation, partner with Operations and Facilities, and contribute to QMS improvements in a regulated xenotransplantation environment.

Qualifikationen

• Experience in GMP/QSR regulated environment required.
• Experience supporting regulatory inspections (FDA, USDA) as SME.
• Ability to review/approve controlled documents and CAPAs.
• Strong analytical judgment and risk assessment skills.
• Experience with environmental monitoring governance in QC microbiology.
• Knowledge of quality systems and continuous improvement.

Aufgaben

• Provide operational leadership for on-site QA/QC microbiology and environmental monitoring.
• Lead deviation management and CAPA execution with timely effectiveness verification.
• Oversee qualification, program design reviews, trending, and inspection readiness.
• Serve as senior QA approver of MasterControl documents and quality records in TrackWise.
• Coordinate supplier qualification for microbiological consumables and labs.
• Support QMS initiatives, validation plans, and a culture of right-first-time.

Kenntnisse

GMP/QSR knowledge

QC microbiology

Environmental monitoring

CAPA & root cause

QA documentation

FDA/inspections

TrackWise

MasterControl

Ausbildung

Bachelor's degree in Life Sciences

Master's degree (preferred)

Tools

MasterControl

TrackWise

Jobbeschreibung

United Therapeutics Corporation seeks an experienced QA/QC Manager to lead on-site QA/QC microbiology and environmental monitoring at the Designated Pathogen-Free facility in Houston, TX. You will drive deviation and CAPA programs, ensure inspection readiness, and align QC with operations.

You will oversee MasterControl and TrackWise documentation, partner with Operations and Facilities, and contribute to QMS improvements in a regulated xenotransplantation environment.