Center Quality Manager I — QA & Compliance Lead

Octapharma Plasma, Inc.; Grand Rapids (MI); Vor Ort; USD 70.000 - 110.000; Vollzeit

Benefits dieser Stelle

Healthcare benefits

HSA

FSA

Tuition reimbursement

401k

Paid time off

Holidays

Personal time

Zusammenfassung

Octapharma Plasma, Inc. is seeking a Center Quality Manager I to ensure compliance with FDA, EMA, and local regulations while safeguarding donor safety. This role operates independently from center Operations and collaborates with the Operations team to uphold product quality and regulatory standards.

You will lead QA activities, manage audits, training, and CAPA processes, and contribute to continuous improvement in a fast‑growing plasma donation network across the United States.

Qualifikationen

• One year of experience in a Quality Assurance role.
• Experience with quality management systems (QMS) and quality control processes.

Aufgaben

• Operate independently of plasma center Operations to ensure compliance with all applicable regulations and industry standards.
• Maintain current knowledge of regulations affecting plasma collection and donor safety.
• Report critical incidents and trends to the Operations team and Regional Quality Director.
• Collaborate with Operations to ensure product quality and donor safety.
• Monitor quality performance indicators, deviations, CAPAs, and complaints.
• Oversee QA processes including donor screening, plasma collection, storage, and shipping.
• Perform final QA review and release for shipments and documents.

Kenntnisse

Quality Assurance

Regulatory compliance

SOPs

Ausbildung

B.S. degree

Jobbeschreibung

Octapharma Plasma, Inc. is seeking a Center Quality Manager I to ensure compliance with FDA, EMA, and local regulations while safeguarding donor safety. This role operates independently from center Operations and collaborates with the Operations team to uphold product quality and regulatory standards.

You will lead QA activities, manage audits, training, and CAPA processes, and contribute to continuous improvement in a fast‑growing plasma donation network across the United States.