**JOB SUMMARY** **Responsible for providing support to the Operations Department in three key areas: 1) temporary direct support to plasma collection centers to address a specific deficiency or serve as an interim Center Manager; 2) provide operations expertise in the execution of corporate projects; and 3) support new plasma collection center development projects. Also, operates within the scope of EU Good Practice Guidelines and FDA’s current Good Manufacturing Practice/21CFR.** **ESSENTIAL JOB FUNCTIONS** **Every effort has been made to make your job description as complete as possible. However, that in no way states or implies that these duties/responsibilities are the only duties you will be required to perform. The omission of specific duties/responsibilities does not exclude them from the position if the work is similar, related or is a logical assignment to the position.** **MAIN DUTIES AND RESPONSIBILITIES** **Daily Operations Management** + Performs opening and closing duties (e.g., powering on/off equipment, documents petty funds and donor fund disbursement, locking up monies and files, maintains alarm system, etc.) as required. + Manages reception area (e.g., steady flow of production, special program monitoring documentation, plasma collection center logs and record, etc.) as needed. + Ensures reception area, plasma room, and donor floor are well-stocked to handle current and next day's production. + Maintains daily, weekly, or monthly reporting documents (e.g., Donor Fees Reporting, Softgoods Inventory, Haemonetics Reports, PCS2 Logs and Event Tracking Logs, Payroll, Production reporting, etc.). + Ensures daily completion of plasma collection center logs and records (i.e., Final Weight sheets, Shipping Temperature Records, Quality Control Records). + Ensures timely response to alarms and maintains alarm system. **Problem Resolution** + Maintains all aspects of daily plasma collection center functions (e.g., personnel, products, donors, computers, etc.). + Keeps immediate supervisor informed of any irregularities within the plasma collection center and provides constructive information about process improvements including resolutions. + Minimizes plasma collection center liability through risk management review including review of Medical Incident Reports, minor incident logs, and drives effective, timely corrective actions. + Manages all donor incidences including donor red cell loss, over/under draws, donor reactions and behavioral issues timely. + Recommends donor recruitment techniques and manages customer and donor complaints through to resolution. **Operations Coverage** May be deployed in an _interim role_ as Center Manager (i) to a plasma collection center in the absence of a center manager (ii) to a center experiencing significant operational challenges. In these instances, the following duties apply: + Manages/oversees all operational aspects, including production, quality performance, people management, equipment, and plasma inventory management/shipping processes. + Trains new plasma collection center management staff and provides direct supervision of center employees. + Provides management support to new plasma collection centers, including equipment installation/qualification and center set up, recruiting of center staff, center leadership training, and support of opening and 90-day production volume ramp up targets. + Participates and supports operations driven projects related to continuous process improvement such as SOP updates, training, inventory, investigations and/or other needs as directed by leadership. **Operational Compliance Oversight** + Ensures compliance of all plasma collection center activities with KEDPLASMA SOPs and other Company standards and protocols meet the regulatory requirements of the FDA, EMEA, Customer Specifications, and other regulatory bodies as required. + Evaluate and support center specialty program utilization of available checklists/tools. + Directs and supervises plasma collection center employees to maintain quality assurance procedures. + Trains employees to maintain daily center operations. + Ensures professional customer service skills, courtesy, and respect are utilized by plasma collection center staff to maximize donor retention. + Identifies all potential, serious, or chronic problems affecting quality or compliance. **Fiscal and Administrative Duties** + Works with Center Manager to hire, train, and coordinate plasma collection center employees to ensure a competent, compliant, and quality team that yields production in accordance with company goals. + Works with Center Manager to prepare schedules for volume increases, vacation coverage and absenteeism. + Works with Center Manager to maintain up-to-date personnel records (e.g., employee evaluations, training documentation, attendance, etc.). + Works with Center Manager to ensure appropriate medical staff coverage is in place or replacement efforts initiated (e.g., Center Physician, Physician Substitute, etc.). + Maintains plasma collection center operations with fiscal responsibility in compliance with current Good Manufacturing Practices (cGMP), Quality Assurance Programs (QAP), and general housekeeping. + Oversees reactive units’ test results and completes unit disposition and paperwork follow through. This includes NAT Testing protocols and awareness of Viral Marker IQPP Standards. **General** Must be able to execute all terms and conditions set forth in the **KEDPLASMA** **Employee** **Handbook** , including, but not limited to: + Work in a safety-conscious manner which ensures that safe work practices are used in order not to pose a risk to self or others in the workplace. + Comply with company Global Code of Conduct and company’s policies and procedures and all the applicable regulations. + Maintain a dependable attendance record and adhere to standards of cleanliness, grooming, hygiene, and dress code. + Attend and participate in scheduled training, educational classes, and meeting(s) in a timely manner as instructed by supervisor/manager. + Cooperate with department personnel, as well as other center staff to ensure services can be adequately maintained to meet the needs of the donors. + Meet with supervisor/manager on a regular basis to assist in identifying and correcting problem areas and/or improving services. + Complete all assigned tasks in a timely manner as instructed by supervisor/manager. + Adhere to work schedules in completing and performing assigned tasks. + Promote KEDRION Values: Together as One; Care; Integrity; Sustainable Impact; and Courage. + Create and maintain an atmosphere of warmth, personal interest, and positive emphasis, as well as a calm environment. + Interact in a tactful, diplomatic, and humanistic manner with donors, visitors, and co-workers to provide a safe, efficient, and caring environment which ensures the self-respect, personal dignity, physical safety of each donor and center guest. + Treat donors, visitors, and co-workers with courtesy, respect, and dignity. + Perform any miscellaneous duties or work assignments, as required. **Physical Requirements** Work is primarily light in nature, with exerting up to 50lbs of force occasionally and/or a negligible amount of force frequently to lift, carry, push, pull or otherwise move objects. Use of fingers to type and / or enter numbers on keyboards, keypads, etc. along with grabbing object(s). Additionally includes, reaching, handling, talking, hearing, bending, stooping, and walking. Involves sitting, standing, and walking most of the time. **Working Conditions** + Primarily inside with well-lighted and well-ventilated areas. + Exposure to Blood Borne Pathogens. + Exposure to an environment with a temperature of -40°C for short periods of time. **Travel** + Travel as needed for at least 75% of working time to plasma collection centers and other KEDPLASMA/Kedrion locations, which includes overnight travel. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.