Specialist, Quality Assurance

Role Summary

Specialist, Quality Assurance. Responsible for ensuring center activities are performed in accordance with SOPs and that the center is ready for regulatory inspections. Assists in development of policies and processes to reduce errors, and monitors quality initiatives and programs including investigations of deviations and root cause analysis.

Responsibilities

• Assures Plasma Center(s) are in compliance with applicable state, federal, and European guidelines.
• Report deviations (cGMP) or regulatory practices to the Quality Director.
• Ensure SOPs, policies, and practices are updated and staff perform in accordance with SOPs through audits and observations.
• Authorize release of final product and stop shipment of non-compliant or non-conforming product.
• Ensure accurate labeling and documentation of shipments.
• Maintain state of readiness for regulatory and customer audits.
• Track and trend errors, implement corrective actions, and approve preventative actions.
• Report compliance status to necessary parties.
• Ensure accuracy of electronic donor records in the donor center system.
• Ensure all supplies and materials meet quality regulations before use.
• Monitor and document maintenance and calibration of equipment as required.
• Ensure training of new employees and annual competency training for existing staff.
• Oversee execution, documentation, and review of internal and external audits.

Qualifications

• Bachelor‚Äôs degree or equivalent professional experience.
• One year of Quality Assurance experience in a Donor Center or similar QA/medical field experience.

Skills

• Ability to follow cGMPs and procedures with high attention to detail.
• Ability to work under pressure with strict deadlines.
• Basic computer skills (Word, Excel, GroupWise).
• Strong goal orientation and problem-solving abilities; able to work with diverse groups.
• Exceptional organizational and communication skills.

Education

• Bachelor‚Äôs degree or equivalent professional experience.

Additional Requirements

• None specified beyond described responsibilities and qualifications.