Plasma Center Quality & Compliance Lead

LifeStream Blood Bank

El Paso (TX)

On-site

USD 65,000 - 95,000

Full time

14 days+
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Job summary

PlasmaShare is seeking a Quality Manager to oversee the review of quality systems and regulatory compliance across technical and clinical operations at plasma centers. The role emphasizes maintaining compliance with local, state, and federal regulations and serving as a resource to operations on quality issues.

Under supervision, you will lead audits, manage deviations, document findings, and coordinate with regulatory bodies while supporting continuous improvement in SOPs, training, and quality

Qualifications

  • Bachelor’s degree in Clinical/Medical Laboratory Sciences or related field.
  • CLS/MLS license or eligibility; RN or equivalent quality credential preferred.
  • Experience with quality systems and regulatory affairs in biologics or medical devices is desirable.

Responsibilities

  • Assist in reviewing and ensuring compliance with SOPs and regulations.
  • Plan and conduct internal audits; prepare reports and corrective actions.
  • Manage deviations, root cause analysis, and verify effectiveness of corrective actions.
  • Assist in regulatory submissions and recalls management as needed.
  • Support supplier and change management processes and quality reviews.

Skills

Quality systems
Regulatory compliance
Auditing
Documentation
Data analysis
Communication
Confidentiality
Travel readiness

Education

Bachelor’s Degree in Clinical/Medical Laboratory Sciences
Quality certification preferred

Tools

MS Office (Word/Excel/Access)

Job description

PlasmaShare is seeking a Quality Manager to oversee the review of quality systems and regulatory compliance across technical and clinical operations at plasma centers. The role emphasizes maintaining compliance with local, state, and federal regulations and serving as a resource to operations on quality issues.

Under supervision, you will lead audits, manage deviations, document findings, and coordinate with regulatory bodies while supporting continuous improvement in SOPs, training, and quality

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