Assistant Quality Assurance Manager
This position is responsible for the leading the quality assurance team, administering and/or implementing programs within the Plasma Logistics Centers. NOTE: This is NOT a remote position.
• Supervises, prioritizes and directs the daily activities of the PLC Quality System Associates (QSAs). Ensures that required activities related to handling of unsuitable units are completed.
• Primary responsibility for the Quality Assurance release of plasma from the PLC in accordance with company SOPs. Verifies that all shipment contents meet SOP, regulator and customer specification requirements prior to release. Maintains a thorough working knowledge of customer requirements to identify and prevent potential shipment errors. Utilizes the integrated and plasma inventory management system LOGIC to prepare and release plasma shipments.
• Responsible for oversight and periodic audits, to confirm the process of managing lookbacks and other unacceptable units is properly performed by the QSA according to current SOPs for each of the systems in use at the PLC.
• Primary responsibility for the verification of incoming shipments of source or recovered plasma to the PLC. Performs quality acceptance functions in LOGIC as appropriate after ensuring that shipment meets all temperature, labeling and documentation requirements. Manages all information regarding any nonconformity noted within the appropriate system and maintain hard-copy documentation to provide customer-specified information to final consignee at time of shipment.
• Ensures the quality review of both incoming and outgoing shipments of intermediates (cryoprecipitate, pastes). Confirms customer supplied material is accurately selected and packed for shipment to the final consignee and appropriate documentation regarding any nonconformities is maintained and provided to the customer per specification.
• When required, investigates and documents deviations noted as a result of routine compliance reviews, internal/external audits and/or customer complaints. Gather appropriate data to determine root cause. Collaborates with Operations and QA Management in the development of appropriate corrective action and follows up to ensure timely closely of deviation reports. Coordinates exchange of information and follows-up activities with Corporate Customer Complaint Management per current SOPs.
• Manages oversight of temperature-monitoring systems & devices at the facility. Monitors the computer-control (facility temperature control system) on a daily basis to ensure system is functioning properly and those acceptable temperatures are being maintained throughout the system. Reviews temperature charts and logs on a weekly basis (at time of change) to ensure documentation is complete, accurate and within acceptable limits.•
• Bachelor’s Degree preferred
• Equivalent combination of education and professional work experience required
• Minimum 1 year supervisor, leadership experience responsible for overseeing the activities of others, OR
• 1 year Quality experience required OR completion of CSL Plasma Leadership Development Program
• 2 years’ experience in an FDA-regulated industry required