Quality Assurance Lead - Plasma Center

Octapharma Plasma; Independence (MO); On-site; USD 70,000 - 100,000; 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

Paid time off

Personal time

Job summary

Octapharma Plasma in Independence, MO is seeking a Center Quality Manager I to ensure compliance with FDA/EMA regulations and to oversee QA processes across donor screening, plasma collection, storage, and shipping.

The role requires a B.S. degree preferred and one year of QA experience, along with strong leadership, analytical skills, and attention to detail. Flexible hours and ongoing training and comprehensive benefits are provided.

Qualifications

• Leadership and communication skills required.
• Strong analytical and problem-solving abilities.
• Detail-oriented with good regulatory knowledge.

Responsibilities

• 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).
• 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.
• Maintain current knowledge of regulations and standards affecting plasma collection and donor safety.
• Execute QA policies and procedures to comply with regulatory requirements.
• Oversee the quality control processes, including donor screening, plasma collection, storage, and shipping.
• Monitor and review quality performance indicators, including deviations, CAPAs, and complaints.
• Perform final QA review and release for all product shipments and associated documents to ensure shipment meets customer specifications.
• Ensure QC checks and validation activities are performed in accordance with SOP.
• Equipment maintenance and calibration documentation comply with SOPs.
• Proficiency surveys and CLIA-required competency assessments are performed on time.
• Prepare agenda and lead monthly QA meetings; communicate minutes to staff.
• Serve as Designated QA Trainer.
• Prepare for and lead internal and external audits and inspections.
• Perform root cause analysis and implement corrective/preventive actions.

Skills

Leadership

Communication

Analytical skills

Problem solving

Education

B.S. degree preferred

Tools

QMS (Quality Management System)

SOP compliance

Job description

Octapharma Plasma in Independence, MO is seeking a Center Quality Manager I to ensure compliance with FDA/EMA regulations and to oversee QA processes across donor screening, plasma collection, storage, and shipping.

The role requires a B.S. degree preferred and one year of QA experience, along with strong leadership, analytical skills, and attention to detail. Flexible hours and ongoing training and comprehensive benefits are provided.