Quality Assurance Leader - Plasma Center Operations

Octapharma Plasma, Inc.; Albuquerque (NM); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, and vision

Health Savings Account (HSA)

Flexible Spending Account (FSA)

Tuition Reimbursement

Employee Assistance Program (EAP)

Wellness program

Paid time off

Personal time

401k

Hospital Indemnity Plan

Legal Plan

Supplemental Life

Short- and Long-Term Disability

Paid Parental Leave

Job summary

Octapharma Plasma, Inc. is seeking a Center Quality Manager I to lead quality assurance efforts at our Albuquerque plasma center. The role ensures regulatory compliance, oversees QC processes, and drives CAPA programs to protect donor safety and product quality.

The ideal candidate has a B.S. degree and at least one year in QA, with strong knowledge of FDA/EMA/ISO standards and experience with QMS and cross-functional teams. This position requires day/evening hours and weekend coverage as needed.

Qualifications

• B.S. degree preferred; other combinations of education and experience may be considered.
• One year experience in a QA role required.
• Demonstrated knowledge of FDA, EMA, ISO, and other regulatory standards applicable to plasma collection and handling.
• Experience with quality management systems (QMS) and quality control processes preferred.
• Strong leadership and communication skills, with the ability to work effectively with cross-functional teams.
• Detail-oriented with excellent problem-solving and analytical skills.

Responsibilities

• Operate independent of plasma center Operations to ensure compliance with all applicable federal, state, and local regulations, as well as industry standards (e.g., FDA, EMA).
• Report critical incidents and negative trends to plasma center Operations team and Regional Quality Director.
• Collaborate with the plasma center Operations team to ensure product quality and donor safety.
• Maintain current knowledge of regulations and standards affecting plasma collection and donor safety.
• Execute QA policies and procedures to comply with regulatory requirements.
• Oversee the quality control processes, including donor screening, plasma collection, storage, and shipping.
• Monitor and review quality performance indicators, including deviations, CAPAs, and complaints.
• Perform final QA review and release for all product shipments and associated documents to ensure shipment meets customer specifications.

Skills

Quality Assurance

Regulatory knowledge

Leadership

Communication

Analytical skills

Problem-solving

Education

BS degree

Tools

QMS

SOP compliance

Job description

Octapharma Plasma, Inc. is seeking a Center Quality Manager I to lead quality assurance efforts at our Albuquerque plasma center. The role ensures regulatory compliance, oversees QC processes, and drives CAPA programs to protect donor safety and product quality.

The ideal candidate has a B.S. degree and at least one year in QA, with strong knowledge of FDA/EMA/ISO standards and experience with QMS and cross-functional teams. This position requires day/evening hours and weekend coverage as needed.