Quality Assurance Lead – Plasma Center Operations

Octapharma Plasma, Inc.; Independence (MO); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Formal training

Health 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, Inc. in Independence, MO seeks a Center Quality Manager I to lead QA activities, ensure regulatory compliance, and supervise audits and investigations. You will collaborate with Operations to maintain product quality, donor safety, and adherence to FDA/EMA/ISO standards.

Ideal candidates have a B.S. degree, 1 year QA experience, and strong leadership plus analytical skills. This on-site role offers growth within a rapidly expanding plasma donation network and a comprehensive

Qualifications

• One (1) year experience in a Quality Assurance role required.
• Demonstrated knowledge of FDA, EMA, ISO, and other regulatory standards applicable to plasma collection and handling required.
• Experience with quality management systems (QMS) and quality control processes preferred.
• Strong leadership and communication skills, with the ability to work effectively with cross-functional teams required.
• Detail-oriented with excellent problem-solving and analytical skills required.
• Demonstrated proficiency in office software.

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 (Corrective and Preventive Actions), and complaints.
• Perform final QA review and release for all product shipments and associated documents to ensure shipment meets customer specifications.
• Ensure: Quality Control (QC) checks and validation activities are performed in accordance with SOP.
• Equipment maintenance and calibration documentation comply with Standard Operating Procedures (SOPs).
• Proficiency surveys and CLIA-required competency assessments are performed in accordance with the required timeframes defined in SOP.
• Prepare agenda and lead monthly Quality Assurance Meeting to discuss SOP changes and regulatory requirements are conducted, documented and minutes are communicated to all donor center staff.
• Serve as Designated QA Trainer.
• Prepare for and lead internal and external audits and inspections.
• 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 the investigation of trends resulting from failures in the execution of procedures.

Skills

QA experience

Regulatory knowledge

Leadership

Communication skills

Detail-oriented

Education

B.S. degree preferred

Job description

Octapharma Plasma, Inc. in Independence, MO seeks a Center Quality Manager I to lead QA activities, ensure regulatory compliance, and supervise audits and investigations. You will collaborate with Operations to maintain product quality, donor safety, and adherence to FDA/EMA/ISO standards.

Ideal candidates have a B.S. degree, 1 year QA experience, and strong leadership plus analytical skills. This on-site role offers growth within a rapidly expanding plasma donation network and a comprehensive