Specialist, Quality Assurance

Role Summary

Specialist, Quality Assurance at ADMA Biologics. Responsible for ensuring center activities comply with SOPs and that the center is prepared for regulatory inspections. Supports development of policies, procedures, and processes to minimize errors, and assists in data gathering and investigation of deviations with root-cause analysis and CAPA as needed.

Responsibilities

• Assure the Plasma Center(s) are in compliance with applicable state, federal, and European guidelines.
• Report deviations (cGMP) or regulatory practices to the Quality Director.
• Update and validate SOPs, policies, and practices; ensure staff perform in accordance with SOPs via audits and observations.
• Authorize release of final product and stop shipments that do not meet compliance or customer specifications.
• 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.
• Verify supplies and materials meet quality regulations prior to use.
• Monitor and document maintenance and calibration of equipment as required.
• Ensure training for new employees and annual competency training for existing staff.
• Oversee execution, documentation, and review of internal and external audits.

Qualifications

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

Skills

• Ability to follow cGMPs and procedures with high attention to detail.
• Ability to work in a high-pressure, deadline-driven environment.
• Basic computer skills (Word, Excel, GroupWise).
• Strong goal orientation, obstacle avoidance, and deadline management.
• Ability to work with diverse groups of people.
• Exceptional organizational and communication skills.
• Maintains competence with required tasks and time management.

Education

• Bachelor’s degree or equivalent professional experience.

Additional Requirements

• Compliance with ADMA Quality policies, standards, and SOPs; timely completion of QA records, HR policies, and EH&S procedures; escalation as needed.