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Job Description Summary Under limited direction, this position is responsible for the overall management of the Analytics and Result Review Quality Assurance teams for a specific laboratory location. The Quality Site Administrator monitors and evaluates the quality system for compliance with applicable regulations, improvement initiatives, and business needs. This role closely partners with laboratory operations teams to ensure the laboratory meets current production requirements in a manner compliant with laboratory quality standards and current regulatory guidelines. Job Description PRIMARY DUTIES AND RESPONSIBILITIES Manages the Quality Assurance (QA) team for a specific laboratory location. Manages day-to-day quality production activities to ensure consistency and compliance across quality review, test result reporting, and donor deferral activities (plasma industry specific). Ensures appropriate staffing, development, training, and problem resolution across two or more shifts. Hires, supervises, trains, and evaluates the performance of assigned staff. Fosters a strong culture of empowerment, accountability, and inclusion, and seeks to develop team capabilities as well as foster personnel growth. Plans and analyzes workflow, delegates and prioritizes activities, and ensures assignments and projects are completed in a timely manner within budget. Ensures system output meets current requirements for laboratory quality standards and current regulatory guidelines. Manages and escalates quality and compliance issues to the attention of stakeholders based on risk to CTS and the clients served. Resolves complex problems and provides issue resolution. Manages laboratory tracking and trending data collection, analysis, and presentation for monthly Quality Management Review meetings. Facilitates proactive solutions based on quality data results. Leads the error management program. Supports operations by managing or performing evaluation of observations and errors. Works with involved departments to perform investigations, root cause analysis, and develop corrective action. Performs follow-up on audit observations. Tracks responses, monitors implementation and ensures the effectiveness of corrective action Leads and participates in process design activities for new and changed processes in identified operations. Participates in review teams to evaluate nonconforming products, materials, or test results and assesses the impact on customers. Ensures required actions are implemented. Advocates and leads annual and quarterly objectives as determined by laboratory leadership. Assists in the oversight of Clinical Trial Studies. Champions OE culture within areas of responsibility and actively encourages team member involvement. Implements and maintains appropriate leading and lagging indicators, which monitor process and product quality and effective execution of standard procedures. Partners with identified departmental leads on mitigating risks in processes, performance, or other factors that influence laboratory quality. Actively builds relationships to influence and collaborate cross-functionality. Facilitates and coordinates the CAPA program, which includes overseeing the successful implementation of and monitoring the efficacy of CAPAs. Ensures the analytic and result review processes meet regulatory standards and business needs. Acts as host and primary liaison for external and internal inspections/audits including, providing written responses as applicable. Ensures corrective actions were implemented and effective. Manages and facilitates recalls and market withdrawals. May perform review of documents as defined by CTS systems to ensure control of processes and adherence to cGMP requirements. Assures quality customer service to all customers. Performs all assigned duties in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management. Performs all other duties, at the discretion of management, as assigned. REQUIRED QUALIFICATIONS Education: Bachelor's degree in science or quality related field required. Experience: Must possess at least five (5 ) years related experience in quality assurance in a Biological/Pharmaceutical environment required To include: previous supervisory or management experience, and previous project or technical leadership. Depending on the area of assignment, directly related experience or a combination of directly related education and/or competencies may be considered in place of the stated requirements. Must possess demonstrated proficiency with Quality Assurance programs, systems and procedures including quality benchmarking, risk management, continuous improvement programs and industry specific regulations.
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