Specialist, Quality Assurance

Role Summary

Specialist, Quality Assurance

Responsibilities

• 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.

Qualifications

• Education Requirements:
  • Bachelor‚Äôs 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.

Skills

• Ability to follow the cGMP‚Äôs and procedures with great attention to detail
• Able to work in high-pressure, deadline-driven environment
• Basic computer skills including experience with software programs such as Word, Excel, and GroupWise
• Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines
• Demonstrated ability to work well with people from diverse backgrounds
• Exceptional Organizational And Communication Skills Required
• Maintains competence with all position required tasks
• Managing Time