Center Quality Manager I — QA, Training & Compliance

Octapharma Plasma, Inc.; Youngstown (OH); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Formal training

Medical, dental, and vision insurance

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. seeks a Center Quality Manager I to lead QA in our donation centers across the region. You will ensure regulatory compliance and drive continuous improvement in product quality and donor safety.

Join a fast-growing team focused on training, audits, and cross-functional collaboration with Operations, Regulatory, and Quality staff. This role requires QA experience and a BS degree or equivalent.

Qualifications

• B.S. degree preferred; other combinations of education and experience may be considered.
• One year experience in a Quality Assurance role required.
• Experience with quality management systems (QMS) and quality control processes preferred.

Responsibilities

• Operate independent of plasma center Operations to ensure compliance with all applicable regulations and industry standards.
• 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, and complaints.
• Oversee 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.

Skills

Quality Assurance

Regulatory Compliance

Audit Management

Cross-functional Collaboration

Education

B.S. degree preferred

Job description

Octapharma Plasma, Inc. seeks a Center Quality Manager I to lead QA in our donation centers across the region. You will ensure regulatory compliance and drive continuous improvement in product quality and donor safety.

Join a fast-growing team focused on training, audits, and cross-functional collaboration with Operations, Regulatory, and Quality staff. This role requires QA experience and a BS degree or equivalent.