Plasma Center Quality Assurance Lead

Biolife Plasma Services; Latham (NY); On-site; USD 67,000 - 92,000; Full time

Job summary

BioLife Plasma Services in Latham, NY, seeks a Center Quality Assurance professional to monitor operations ensuring compliance with cGMP, the Shire Quality System, and FDA-regulated standards. The role emphasizes stopping operations or shipments if safety is compromised.

You will review records, track deviations, coordinate audits, supervise training, and support center management in implementing corrective actions.

Qualifications

• Essential: High School Diploma or equivalent required.
• Desirable: Associates or Bachelor’s degree.
• Minimum one year of relevant work experience or equivalent education.
• Experience in a medical or regulated field is desirable.

Responsibilities

• Regulatory Compliance: stay current with federal, state, local and company rules; ensure center compliance and up-to-date SOPs.
• Plasma Collection Center QA Oversight: review records for completeness and cGMP compliance; track deviations and observations; oversee audit readiness.
• Employee Recruitment and Retention: provide feedback and develop staff, conduct evaluations, and ensure high levels of customer service.

Skills

Quality assurance

Organizational skills

Problem-solving

Education

High School Diploma or equivalent

Associates or Bachelor’s degree desirable

Tools

Word processing

Excel

Databases

Data analysis

Job description

BioLife Plasma Services in Latham, NY, seeks a Center Quality Assurance professional to monitor operations ensuring compliance with cGMP, the Shire Quality System, and FDA-regulated standards. The role emphasizes stopping operations or shipments if safety is compromised.

You will review records, track deviations, coordinate audits, supervise training, and support center management in implementing corrective actions.