Center QA Lead - GMP, Audits & Compliance

Octapharma Plasma; West Palm Beach (FL); In loco; USD 90.000 - 120.000; Tempo pieno

Vantaggi offerti da questo lavoro

Formal training

Medical insurance

Dental insurance

Vision insurance

Health Savings Account

Flexible Spending Account

Tuition reimbursement

Employee assistance program

Wellness program

401k plan

Paid time off

Company holidays

Personal time

Descrizione del lavoro

Octapharma Plasma in West Palm Beach, FL seeks a QA Manager I to join the plasma center management team. You will ensure all activities related to plasma collection, donor eligibility, and product quality comply with FDA, EMA, and company policies.

You will lead audits, oversee QC processes, and drive CAPAs while training staff on GMP and SOPs to maintain the highest quality standards in donor safety and product integrity.

Competenze

• 1 year of experience in a QA role is required.
• Experience with QMS and quality control processes preferred.
• BS degree or equivalent and relevant QA training are desirable.

Mansioni

• Ensure compliance with all applicable regulations and standards (FDA, EMA, local).
• Maintain knowledge of regulations affecting plasma collection and donor safety.
• Lead audits and inspections; prepare audit responses and track corrective actions.
• Oversee donor screening, plasma collection, storage and shipping quality.
• Perform QA reviews and final release for shipments and documents.
• Deliver QA training on GMP, SOPs and regulatory compliance.
• Lead QA meetings and communicate regulatory updates to staff.

Conoscenze

Quality Assurance

Regulatory compliance

Audits

Training development

Formazione

B.S. degree preferred

Strumenti

Quality Management System (QMS)

Descrizione del lavoro

Octapharma Plasma in West Palm Beach, FL seeks a QA Manager I to join the plasma center management team. You will ensure all activities related to plasma collection, donor eligibility, and product quality comply with FDA, EMA, and company policies.

You will lead audits, oversee QC processes, and drive CAPAs while training staff on GMP and SOPs to maintain the highest quality standards in donor safety and product integrity.