Center Quality Manager I

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Overview

This role serves as a member of the plasma center management team. The position will ensure all activities and processes related to plasma collection, donor eligibility, and product quality comply with regulatory requirements, industry standards, and company policies.

Responsibilities

• Operate independently of plasma center operations to ensure compliance with all federal, state, local, and industry regulations (e.g., FDA, EMA).
• Report critical incidents and negative trends to the Operations team and Regional leadership; collaborate with Operations 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 requirements.
• Oversee quality control processes, including donor screening, plasma collection, storage, and shipping; ensure QC checks, validations, equipment calibration, and CLIA assessments are performed according to SOPs.
• Monitor and review quality performance indicators, including deviations, CAPAs, and complaints; lead monthly Quality Assurance meetings to discuss SOP changes and regulatory requirements.
• Conduct final QA review and release of all product shipments and associated documents to ensure compliance with customer specifications.
• Serve as Designated QA Trainer, developing and delivering training on GMP, SOPs, and compliance; provide direction and oversight to Quality backup staff and participate in QA staff selection.
• Prepare for and lead internal and external audits; maintain audit records and ensure timely completion of audit responses and corrective actions.
• Perform root cause analyses, implement CAPAs, and conduct effectiveness checks for systemic issues.
• Continuously assess, promote, and improve quality systems by investigating trends, supporting continuous improvement initiatives, and monitoring outcomes.
• Provide leadership in the implementation of changes, adjusting strategies as necessary to strengthen quality and compliance.
• Perform other duties as assigned.

Qualifications

Physical Requirements

Location : Elgin, IL

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