ESSENTIAL JOB FUNCTIONS:

1. Regulatory Compliance and Quality Assurance:

a. 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).

b. Reports critical incidents and negative trends to plasma center Operations team and Regional Quality Director.

c. Collaborate with the plasma center Operations team to ensure product quality and donor safety.

d. Maintain current knowledge of regulations and standards affecting plasma collection and donor safety.

e. Execute QA policies and procedures to comply with regulatory requirements.

f. Oversee the quality control processes, including donor screening, plasma collection, storage, and shipping.

g. Monitor and review quality performance indicators, including deviations, CAPAs (Corrective and Preventive Actions), and complaints.

h. Perform final QA review and release for all product shipments and associated documents to ensure shipment meets customer specifications.

i. Ensure:

i. Quality Control (QC) checks and validation activities are performed in accordance with SOP.

ii. Equipment maintenance and calibration documentation comply with Standard Operating Procedures (SOPs).

iii. Proficiency surveys and CLIA-required competency assessments are performed in accordance with the required timeframes defined in SOP.

iv. 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.

2. Training and Development:

a. Serve as Designated QA Trainer and responsible for training Quality backup staff and Plasma Center Quality Manager I

b. Develop and deliver training programs for staff on quality-related topics, including GMP (Good Manufacturing Practice), SOPs (Standard Operating Procedures), and regulatory compliance.

c. Participate in the selection process for the Quality Assurance Back-up role.

d. Provide direction and oversight of Quality Back-up staff, ensuring required quality tasks are completed within required time frames.

3. Audits and Inspections:

a. Prepare for and lead internal and external audits and inspections.

b. Develop and implement audit responses ensuring timely completion and adherence to quality standards.

c. Maintain audit records and follow up on audit findings and corrective actions.

4. Continuous Improvement:

a. Perform root cause analysis, implement corrective/preventive actions, and conduct effectiveness checks for systemic issues.

b. 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.

c. Support the implementation of continuous improvement initiatives.

d. Monitor the effectiveness of implemented changes and adjust strategies as necessary.

JOB SPECIFICATIONS AND EXPERIENCE:

1. B.S. degree preferred. Other combinations of education and experience may be considered.

2. One (1) year experience in a Quality Assurance role required.

3. Demonstrated knowledge of FDA, EMA, ISO, and other regulatory standards applicable to plasma collection and handling required.

4. Experience with quality management systems (QMS) and quality control processes preferred.

5. Strong leadership and communication skills, with the ability to work effectively with cross-functional teams required.

6. Detail-oriented with excellent problem-solving and analytical skills required.

7. Demonstrated proficiency in office software.

8. Ability to work day and evening hours, weekends, holidays, and extended shifts.