Christina Dunham

• Independent level of quality inspection and control – ensures center compliance with quality standards and regulations.
• Collaborates with Center Managers to ensure product quality, donor suitability and donor safety.
• Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations.
• Ensures that Standard Operating Procedures (SOPs) are properly interpreted, implemented in a timely fashion, and that the staff performs according to all SOPs.
• Interprets and implements processes, regulations and SOPs for quality control and overall regulatory compliance, making independent decisions and modifications as required.
• Oversight of all aspects of internal and external audits including execution (if applicable). This includes documentation, review of and preparation of the response. Also includes implementation of corrective and preventative action, assessment of corrective and preventative actions and follow-up as required.
• Continuously assesses, promotes, and improves the effectiveness of the quality systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, direct employee observation and review of center documents.
• Responsible for the personnel functions of the Quality Systems Associate(s); including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of all personnel records, management of work schedule and delegation/follow-up of tasks.
• Oversees product and biohazard waste shipments: Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation; and, authorizes final shipment.
• Performs a review of the documentation of unsuitable test results and the disposition of the associated results.
• Works in collaboration with the Center Manager to develop the staff's knowledge of their job function and how their performance relates to the end product and patient.
• Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product.
• Documents and tracks/trends center quality incidents and follows-up on incidents/errors as required; reports critical incidents and problematic trends to Center Manager.
• Reports compliance status to necessary parties.
• Ensures accuracy of donor files.
• Ensures that all supplies and materials ordered meet quality requirements prior to use and are stored in appropriate temperature/facility conditions at all times. Initiates appropriate investigations if these requirements are not met. Initiates rejection of supplies for non-conformance.
• Directs the maintenance and calibration of equipment and documentation of procedures.
• Ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented.
• Monitors training documents to ensure compliance with all applicable policies and procedures.
• Ensures that job and Current Good Manufacturing Practice (cGMP) training is completed, documented, and on file.
• Tracks/Trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness. Makes adjustments where required.
• Ensures that quality control (QC) checks are performed as required and are in acceptable ranges for test reagents.
• QM directs routine verification of the SOP and forms to ensure that they are up to date in the Donor Center's manual.
• Partners with the Center Manager to determine donor suitability activities and manages donor deferrals as appropriate.
• Prepares quality analysis reports to track issues and set goals. Does in depth research and analysis to resolve systemic compliance issues.
• Builds rapport with donors to ensure overall customer satisfaction with the Center to support long-term donation.
• Reviews and approves of deferred donor reinstatement activities.
• Performs a review of lookback information.
• Performs a review of medical incident reports and the applicable related documentation.
• Leads projects and initiatives for the region and division.

● Completes weekly review of equipment QC and maintenance records.

● Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they related to product quality and/or donor safety.

● Inspects and releases incoming supplies. Investigates and reports supplies have not met quality specifications and requirements prior to use.

● Performs documentation review for unsuitable test results.

● Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed. Duties include:

Under the direct supervision of the Quality Systems Manager, perform quality assurance and Training functions to ensure compliance with internal and external regulations and protocol.

● Performs all product release activities.

● Reviews lookback information and documentation.

● Reviews waste shipment documentation.

● Reviews unexpected plasmapheresis events including electronic donor chart and related documentation pertaining to exceptions occurring during the donation process.

● Reviews electronic donor chart exceptions impacting donor eligibility/safety and/or product quality.

● Reviews donor deferral notifications from competitor centers.

● Reviews plasma processing documentation to ensure the proper freezing, storage and handling of product.

● Assist the Quality Systems Manager to ensure center training programs follow procedural requirements as defined in the donor center SOP and/or training programs documents. Duties include:

● Creates, maintains, and audits training records and files to ensure compliance.

● Performs employee training observations to ensure staff competency prior to releasing employees to work independently.

● Conducts required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.

● On an occasional basis, when the Quality Systems Manager is absent, the Quality Systems Associate may be required to perform the following duties:

● Reviews and approves of deferred donor reinstatement activities.

● Assists with completion of the internal donor center audit.

● Performs review of monthly trending report.

● Performs review of donor adverse events reports and the applicable related documentation.

● Conducts training to address donor center corrective and preventative measures.

• Increased donor satisfaction with thorough pre-donation screenings, ensuring eligibility and minimizing risks.
• Maintained accurate donor records through diligent data entry and documentation efforts.
• Enhanced donor experience by providing exceptional customer service and maintaining a clean, organized workspace.
• Ensured donor safety and comfort by closely monitoring vital signs during the donation process.
• Responded promptly to donor inquiries and concerns, demonstrating empathy and understanding to resolve any issues that arose.
• Developed strong rapport with donors through genuine engagement, fostering long-term loyalty and increasing repeat donations.
• Strengthened quality control measures by consistently adhering to established guidelines and best practices during all donation procedures.

• Monitor and achieve profit, sales and performance goals (i.e. reviewing the P&L).
• Optimize and oversee the eyeglass department to ensure efficiency and compliance with company's policies and operational guidelines.
• Convey a commitment to providing outstanding customer service and ensure all associates do the same.
• Ensure quality standards are met. Review remakes and enforce policies to ensure compliance.
• Communicate with the General Manger, District Manager, and Corporate Office and provide store reporting as required.
• Ensure store promotions, advertising, and visual merchandising are in place and all associates and doctors are aware of current promotions.
• Supervise and motivate Opticians and CL Sales associates and ensures the timely completion of day-to-day functions.
• Assist the General Manager with forecasting staffing needs, recruiting, selecting and retaining a high caliber staff.
• Motivate associates to exceed performance standards.