• 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 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 (Good Manufacturing Practice), SOPs (Standard Operating Procedures), and regulatory compliance.
• 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.
• Responsible for mentorship to those in the Plasma Center Quality Manager I role.

• Prepare for and lead internal and external audits and inspections.
• Develop and implement audit responses ensuring timely completion and adherence to quality standards.Interacts with donor center Licensed Physician regarding ordering immunizations.
• Maintain audit records and follow up on audit findings and corrective actions.

• 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.
• Support the implementation of continuous improvement initiatives.
• Monitor the effectiveness of implemented changes and adjust strategies as necessary.

• B.S. degree preferred. Other combinations of education and experience may be considered.
• Two (2) years’ 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.
• Ability to work day and evening hours, weekends, holidays, and extended shifts.

Physical Requirements:

• Ability to sit or stand for extended periods for up to four (4) hours at a time.
• Ability to tug, lift, and pull up to thirty-five (35) pounds.
• Ability to bend, stoop or kneel.
• Ability to enter an environment with a temperature of -40°C for short periods of time.
• Occupational exposure to blood borne pathogens.
• Ability to view video display terminal less than 18” away from face for extended periods of time, up to four (4) hours at a time.
• Ability to perform precise tasks that require repetitive small motor skills, such as drawing blood for diagnostic tests.
• Ability to type and use basic computer skills.
• Ability to use assistive devices if needed for mobility or communication
• Ability to travel via automobile and/or airplane up to 20%.