Plasma QA & Compliance Lead

Octapharma Plasma, Inc.; Visalia (CA); On-site; USD 76,000 - 127,000; Full time

Benefits offered by this job

Health insurance

401k retirement plan

Paid time off

Paid holidays

Tuition reimbursement

EAP

Job summary

Octapharma Plasma, Inc. is seeking a QA leader to join the plasma center management team. You will oversee donor screening, plasma collection QC, and product documentation to ensure compliance with regulatory standards and SOPs.

leadership in GMP training, CAPA implementation, and audit responses, while driving continuous quality improvements across operations. This role requires strong regulatory knowledge and cross-functional collaboration in a fast-paced clinical setting.

Qualifications

• High school diploma or equivalent.
• Bachelor’s degree preferred.
• One year of experience in a Quality Assurance role.
• Experience with quality management systems and quality control processes preferred.
• Knowledge of FDA, EMA, ISO and other regulatory standards.

Responsibilities

• Operate independently to ensure compliance with all regulations and standards.
• Identify, document, and report incidents and CAPA to mitigate risk.
• Oversee QC processes for donor screening, collection, storage, and shipping.
• Monitor quality performance indicators and lead QA meetings.
• Conduct final QA release of shipments and documents.
• Deliver GMP/SOP/compliance training and supervise QA staff.
• Prepare for internal and external audits and close corrective actions.
• Promote continuous improvement of quality systems.

Skills

Leadership

Regulatory knowledge

Quality assurance

Cross-functional collaboration

Problem solving

Quality metrics

Education

Bachelor's degree preferred

High school diploma or equivalent

Tools

Microsoft Office

Job description

Octapharma Plasma, Inc. is seeking a QA leader to join the plasma center management team. You will oversee donor screening, plasma collection QC, and product documentation to ensure compliance with regulatory standards and SOPs.

leadership in GMP training, CAPA implementation, and audit responses, while driving continuous quality improvements across operations. This role requires strong regulatory knowledge and cross-functional collaboration in a fast-paced clinical setting.