Assistant Manager of Quality who specializes in quality, customer service, productivity and team management
Lead and function as the key representative for site supplier, customer and regulatory audits. Lead center review of findings, coordination of remediation (CAPA), if needed and successful closure of audits timely. Utilize quality tools and applications to facilitate understanding of issues and documentation.
Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine audits of internal procedures and documentation, as necessary.
Adhere to all HR policies and practices through fair and equitable treatment of all employees. Communicate effectively with HR to ensure HR compliance and ensure center management is doing the same.
Responsible for hiring, retention and development of quality staff.
Comply with all federal, state and local regulatory and company policies and procedures.
Responsible for notification to the ADOQ for any event that negatively affects the safety, quality, identity, purity or potency of the product that results in pausing or disruption of business. If necessary, notification must be elevated to any of the following, Regional Director, Associate Director of QA, Divisional Director or Director of Quality Systems and Assurance.
Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyper immune programs at the center if applicable.
Lead investigations and deviations to determine root cause, correction/preventative actions and effectiveness checks. Monitor CAPA's and effectiveness checks to ensure issues are resolved.
Participate in Center leadership team meetings to understand center training needs and collaborate with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues.
Responsible for the oversight of the training activities, oversight of CLIA, policies and processes at the Center level.
Perform other quality duties as assigned.
Monitor department workflow and assign daily tasks to Quality Associates.
Monitor staff training, and facilitate cross training to ensure efficient workload management.
Provide guidance to Quality Associates and/or Center Personnel regarding donor and unit suitability criteria.
Communicate with customers, regulatory authorities, other departments, center and laboratory personnel to provide and collect information regarding Lookbacks, BPDRs, and Recall Documentation, as well as to resolve problems.
Communicate with appropriate site Managers to clarify necessary investigation information required for the report.
Ensure Quality Associates submit completed reports to CBER.
Review and update department Standard Operating Procedures (SOPs), as needed.
Provide backup support to the department in processing Lookbacks and/or BPDRs to customers and appropriate regulatory agencies.
Follow all SOPs, company policies and procedures.
Remotely Conduct Virtual Training to multiple centers simultaneously using a virtual platform. Training may include but is not limited to usage of NextGen application in the Plasma Centers, supporting Center Super Trainers and hosting Q & A sessions when needed.
Act as a producer (co-host) as needed for virtual session when not facilitating. While functioning as a producer the Virtual Facilitator's duties may include but is not limited to: supporting the Virtual Facilitator during sessions, filtering questions and comments from the chat room, assisting centers having technical difficulties during facilitation sessions, and assist in scenario setup for the virtual sessions.
Prepare material, equipment, training site and virtual platform before virtual sessions. Verify prep work completed from the center aspect.
Support, audit and maintain the Learning Management System to ensure data integrity, report generation, and data analysis to comply with company and regulatory standards.
Schedule, coordinate and monitor the delivery of all training, to Center Super Trainers and Center Staff to meet center or other training and regulatory requirements. Ensure using the most current version of training materials.
Train consistently on-designated modules, complete demonstrations, guide learners on assignments to be fulfilled post-virtual sessions.
When facilitating multiple sessions, coordinate efforts between sessions and utilize opportunities to gauge center progress.
Monitor training progress in transitioning centers. Ensure all equipment used in the session is adequately working and setup prior to training session.
In the absence of the Center Manager, overall authority over center operations production goals, monitor net yields and implement improvement plans as required. Meet daily, weekly and monthly deadlines and maintain operational records.
Independently determine center labor usage to meet business needs. Support meeting the established center production goals.
Manage all inventories to the optimum levels by maximizing efficiencies and customer service levels.
Ensure efficient donor flow throughout the center. Identify problem areas and implement corrective action as needed.
In collaboration with center manager, ensure compliance with all Company SOPs and applicable federal, state and local regulations. Perform nearly all staff tasks and duties at a proficiency level adequate for training and critiquing employees in the performance of those tasks and duties.
In absence of center manager, responsible for all aspects of financial oversight. Responsible for center production goals.
In collaboration with center manager, support the center philosophy of continuous improvement. Collect and analyze data to maintain and improve center quality, efficiency and profitability. Implement effective corrective action plans when appropriate.
Assist with all audits by working with quality personnel and QA team to develop effective corrective action plans to address any areas of deficiency noted during audits.
Traveling New Center Opening Team
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