Center Quality Manager 1

Center Quality Manager 1 — Octapharma Plasma, Inc.

We're growing fast and offer strong learning and career development opportunities throughout our company and especially in our donation centers. If you love to learn, enjoy working with people, and have a heart to help, consider joining us as a Center Quality Manager 1.

This Is What You'll Do

• 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).
• Maintain current knowledge of regulations and standards affecting plasma collection and donor safety.
• Reports 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.
• Monitor and review quality performance indicators, including deviations, CAPAs (Corrective and Preventive Actions), and complaints.
• Oversee the quality control processes, including donor screening, plasma collection, storage, and shipping.
• Perform final QA review and release for all product shipments and associated documents to ensure shipment meets customer specifications.
• Execute QA policies and procedures to comply with regulatory requirements.
• Quality Control checks and validation activities are performed in accordance with SOP.
• Prepare for and lead internal and external audits and inspections.
• Develop and implement audit responses ensuring timely completion and adherence to quality standards.
• Maintain audit records and follow up on audit findings and corrective actions.
• Serve as Designated QA Trainer and responsible for training Quality backup staff and Plasma Center Quality Manager I.
• Develop and deliver training programs for staff on quality-related topics, including GMP, SOPs, and regulatory compliance.
• Proficiency surveys and CLIA-required competency assessments are performed in accordance with the required timeframes defined in SOP.
• Equipment maintenance and calibration documentation comply with SOPs.
• Perform root cause analysis, implement corrective / preventive actions, and conduct effectiveness checks for systemic issues.
• Continuously assess, promote, and improve the effectiveness of the quality systems in the plasma center through investigation of trends resulting from failures in the execution of procedures.
• Support the implementation of continuous improvement initiatives.
• Monitor the effectiveness of implemented changes and adjust strategies as necessary.
• Prepare agenda and lead monthly Quality Assurance meetings to discuss SOP changes and regulatory requirements, ensuring documentation and minutes are communicated to all donor center staff.
• Participate in the selection process for the Quality Assurance Back-up role.
• Provide direction and oversight of Quality Back-up staff, ensuring required quality tasks are completed within required time frames.
• Perform other duties as assigned.

Qualifications / What It Takes

Physical Requirements

For the full job description, please view the posting at : https : / / careers.octapharmaplasma.com / us / en / center-quality-manager-i

About Octapharma Plasma, Inc.

With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch.

J-18808-Ljbffr