Position Summary

This position is responsible to ensure all center activities are performed in accordance with standard operating procedures (SOPs) and the center is ready for inspection by regulatory agencies at any time.

The Quality Assurance Specialist (QAS) assists in the development of policies, procedures, and processes to ensure the necessary requirements and controls are appropriately addressed in an effort to reduce or eliminate the potential of errors. This may be identified through scheduled audits, performance observations, or record review.

This position assists in the gathering and compilation of data and information to provide appropriate monitoring of all quality initiatives and programs. The QAS is responsible for ensuring an appropriate investigation of any deviations from process or procedure is complete. The investigation may require root cause analysis and effective corrective or preventative actions. Monitoring for the recurrence or the potential for recurrence is a critical component of data analysis.

Essential Functions (ES) and Responsibilities

• Key Duties (E)
  • Assures the Plasma Center(s) is in compliance with all applicable state, federal, and European guidelines.
  • Has the responsibility to report any deviations (cGMP) or regulatory practices to the Quality Director.
  • Assures that SOPs, policies, and practices are updated and validated as applicable and that staff is performing in accordance with SOPs through scheduled audits and direct performance observations.
  • Authorizes the release of final product and has the authority to stop shipment of any product that does not meet compliance or customer specifications.
  • Assures accurate labeling and documentation of shipments.
  • Assures center maintains state of readiness for regulatory and customer audits.
  • Responsible for tracking and trending errors, corrective actions, and the approval of preventative action.
  • Reports compliance status to necessary parties.
  • Assures accuracy of electronic donor records in the applicable donor center system.
  • Assures all supplies and materials meet quality regulations prior to placement into use.
  • Monitors and ensures the maintenance and calibration of equipment is completed and documented as required by procedures.
  • Ensures completion and accuracy of training for new employees and competency training of existing staff on an annual basis.
  • Oversees execution, documentation, and review of internal and external audits.
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Job Responsibilities or Job Requirements

Competencies

Experience Requirements

• Education Requirements:
  • Bachelor’s degree or equivalent professional experience.
• Experience Requirements:
  • One minimum of one year of Quality Assurance experience in a Donor Center or similar Quality Assurance or medical field experience.

Preferred Experience

Compliance Requirements (ES)

• • As a part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all ADMA Quality policies, standards and SOPs in their area of work and responsibility.
  • This includes ensuring all Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner.
  • Any delay or failure to comply with policies, standards and procedures is required to be communicated/escalated to the appropriate responsible parties, such as QA, HR, or EH&S depending on the issue.