Plasma Center Quality Lead — Compliance & QA

Octapharma Plasma, Inc.

Springfield (IL)

On-site

USD 64,000 - 107,000

Full time

1 hour ago
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Benefits offered by this job

Formal training
Outstanding plans for medical, dental,
Health savings account (HSA)
Flexible spending account (FSA)
Tuition Reimbursement
Employee assistance program (EAP)
Wellness program
401k retirement plan
Paid time off
Company paid holidays
Personal time

Job summary

Octapharma Plasma, Inc. in Springfield, IL is seeking a QA Manager to ensure all activities related to plasma collection and product quality comply with FDA, EMA, and company policies.

You will lead QA training, audits, CAPAs, and continuous improvement initiatives, providing direction to QA staff and coordinating with Operations to safeguard donor safety.

This is a full-time role with competitive benefits and opportunities for professional growth in a mission-driven environment.

Qualifications

  • B.S. degree preferred.
  • One year experience in a Quality Assurance role.
  • Experience with quality management systems (QMS) and quality control processes preferred.

Responsibilities

  • Operate independently to ensure compliance with all regulations (FDA, state, local).
  • Report critical incidents and deviations to Operations and Regional leadership.
  • Maintain knowledge of regulations affecting plasma collection and donor safety; enforce GMP/SOP compliance.
  • Oversee QC processes including donor screening, plasma collection, storage, and shipping; ensure QC checks and calibrations are performed per SOPs.
  • Monitor QA metrics, deviations, CAPAs and complaints; lead monthly QA meetings on SOP changes and regulatory updates.
  • Conduct final QA review and release of shipments and associated documents per customer specs.
  • Serve as Designated QA Trainer; deliver training on GMP, SOPs, and compliance; supervise QA staff as needed.
  • Prepare for and lead internal and external audits; maintain audit records and respond to corrective actions.

Skills

Regulatory compliance
Quality Assurance
GMP knowledge
CAPA handling

Education

B.S. degree

Job description

Octapharma Plasma, Inc. in Springfield, IL is seeking a QA Manager to ensure all activities related to plasma collection and product quality comply with FDA, EMA, and company policies.

You will lead QA training, audits, CAPAs, and continuous improvement initiatives, providing direction to QA staff and coordinating with Operations to safeguard donor safety.

This is a full-time role with competitive benefits and opportunities for professional growth in a mission-driven environment.

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