Sterile Compounding Quality Lead & Compliance

Option Care; San Francisco (CA); On-site; USD 100,000 - 166,000; Full time

Job summary

Option Care Health seeks a Sterile Compounding Quality Manager to uphold cleanroom quality, monitor CSP processes, and ensure regulatory compliance nationwide. You will act as the primary quality resource for an operating area, leading CAPA initiatives and collaborating with leadership and the Cleanroom Help team to achieve quality and safety goals.

You will monitor metrics, conduct investigations, provide training, and support ongoing quality improvement, including audits, inspections, and

Qualifications

• PTCB CSPT certification or BPS BCSCP
• Pharmacy technician licensure/registration or pharmacist license
• Experience in infusion therapy or sterile compounding preferred

Responsibilities

• Provide subject matter expert guidance on cleanroom quality and urgent incidents
• Maintain/review cleanroom quality systems and reports
• Lead root cause investigations and CAPA plans
• Conduct quality visits and training
• Prepare and present quality metrics and KPIs
• Support new cleanroom construction/remodels with quality guidance

Skills

CAPA management

Quality metrics analysis

Regulatory compliance

Leadership

Cross-functional collaboration

Education

CSPT certification

Pharmacist license

Tools

Microsoft Excel

Microsoft PowerPoint

Microsoft Word

Job description

Option Care Health seeks a Sterile Compounding Quality Manager to uphold cleanroom quality, monitor CSP processes, and ensure regulatory compliance nationwide. You will act as the primary quality resource for an operating area, leading CAPA initiatives and collaborating with leadership and the Cleanroom Help team to achieve quality and safety goals.

You will monitor metrics, conduct investigations, provide training, and support ongoing quality improvement, including audits, inspections, and