Grifols

Operations

• responsible for directly supporting the Manager of Academy Operations in activities and tasks related to training programs
• managing program logistics
• ensuring compliance requirements are met
• demonstrating Grifols values and culture
• creating and maintaining excellent record keeping practices
• assisting in Academy accreditation activities
• implementing researched-based teaching strategies
• motivating students through effective communication and feedback

Academy Operations Specialist

Bilingual

• Perform physical examination and establish medical history to determine donor suitability
• Build rapport with donors to ensure overall customer satisfaction
• Ensure donor and staff confidentiality
• Responsible for donor awareness to potential hazards
• Provide donor education regarding general health and provide counseling regarding unacceptable test results
• Evaluate & manage donor injuries and adverse events
• Perform evaluations of any history of illness or medications to ensure continued donor suitability
• Assist in employee training
• Administer employee Hepatitis Vaccine program

EMTB/EMT – Advanced/Paramedic, Bilingual in Spanish Preferred

Human Resources

• Provides administrative support with day-to-day operations in the corporate HR shared services center.
• Enters and audits HR transactional data within a centralized HR database and ancillary HR systems.
• Ensures the information is accurate and adheres to corporate standards
• Assists with data entry into HR systems, retrieving / updating employee files, or preparing reports
• Processes diverse and confidential information requiring extreme accuracy, independent judgment and discretion
• Organizes and maintains employee files
• Processes various forms related to documenting HR activities such as new-hire, change-of-status, performance evaluations, benefits, terminations, etc
• Provides support for assigned projects and tasks to ensure successful completion
• Troubleshoots technology issues and identifies solutions, partnering with vendors to complete enhancements and communicating within the HR community.
• Works with IT/vendors/users on resolution and process improvements
• Interacts with HR community to provide data, systems support, and issue resolution
• Ensures data consistency and integrity by owning the development and maintenance of the HR data dictionary, creating and supporting processes to ensure data consistency, performing monthly data audits, identifying and escalating areas for concern, and managing requests for changes to HR data
• Works within the HR function to support government reporting requirements
• Partners with HR functions to apply data and process analysis techniques to identify areas for continuous process improvement
• Acts as primary liaison for HR and, if necessary, to IT for requests for new interfaces or troubleshooting existing data interfaces
• Maintains ownership of HR data processes.
• Develops and maintains standard operating procedures (SOPs) with internal controls
• Analyzes and approves employee data against submitted requests to ensure data accuracy and processing of aligned actions

HR Associate, HR Data Center

Vice President

• Oversees all Quality functions for Grifols Therapeutics.
• Ensures that all biological products, which are manufactured or distributed any GT location, are manufactured and tested in compliance with company specifications and regulatory requirements.
• Directs the establishment of Quality policies, systems, procedures and specifications for raw materials, in-process product, and finished products.
• Establishes Quality systems and practices to assure compliance with state-of-the-art standards, current GMP regulations (domestic and international) and corporate requirements.
• Directs analytical method validations and QC execution to assure that appropriate information is collected, specifications developed, and methods established to assure the approval of IND/NDA's for all biotech compounds researched at GT or any other licenser that will be manufactured.
• Directs Quality activities to insure that clinical supplies meet FDA requirements for Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) that are being used by Grifols clinical investigators to receive approved IND/NDA's on compounds to be marketed.
• Participates in the technical review process and approves all new or modified products to be manufactured by GT before submission to the FDA for approval and/or release to the market.
• Approves all Quality and Manufacturing procedures to ensure that all phases of operations conform to current GMP regulations.
• Assures that contract manufacturers of GT are in compliance with appropriate manufacturing practices and that product contract manufacturers meet the desired quality attributes as verified in GT laboratories.
• Responsible for the establishment of appropriate quality policies, standards, and practices for manufacturing, warehousing, testing, training, release, valiation, documentation, maintenance, etc. at the GT facility.

Vice President, Quality

Program Manager

• Manages the Molecular Donor Screening (MDS) Program end-to-end
• Owns MDS program governance, the integrated master of projects plan
• Ensures aligned strategy, scope, priorities, and governance across the complete MDS portfolio
• Coordinates and engages with all internal and external stakeholders of the Program for goal achievement
• Manages financial performance to ensure projects stay within financial constraints
• Creates and delivers presentations to varying audiences
• Drives integrated resource planning and execution across all functional areas for the MDS Program

Director, Molecular Donor Screening Program Management

Analyst

• Analizar el rendimiento del proceso de producción y monitorizar indicadores clave de rendimiento (KPI).
• Desarrollar y actualizar los costos estándar anuales de los productos fabricados.
• Preparar análisis financieros e informes de gestión orientados a mejorar la eficiencia económica de la planta.
• Participar activamente en los procesos de presupuestación y previsión, proporcionando análisis financieros y apoyo.
• Realizar análisis e informes relacionados con las actividades de cierre mensual, trabajando en estrecha colaboración con el departamento de FSSC para asegurar cierres financieros oportunos y de alta calidad.
• Revisar y realizar análisis financieros de contratos de terceros celebrados por diferentes departamentos de la empresa.
• Actuar como socio financiero de áreas operativas como Producción, Calidad e I+D, proporcionando orientación financiera y apoyo al control.
• Calcular y analizar costos de productos manufacturados.
• Preparar informes estadísticos y reportes requeridos por instituciones oficiales (por ejemplo, INE).
• Apoyar al departamento durante auditorías internas y externas.
• Diseñar y mantener los controles necesarios para asegurar el cumplimiento de SOX.
• Mantener y actualizar los datos maestros de materiales en SAP relacionados con la contabilidad de costos.

Senior Cost Controlling Analyst – Temporary

• Maintain the ability to perform any/all tasks within the plasma center; fulfill the role of production employees and supervise donor flow.
• Learn and maintain thorough familiarity and compliance with all state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP) and internal company procedures.
• Supervise donor selection, plasma collection and all manufacturing records.
• Attend all required training sessions, staff meetings, etc.
• Ensure accurate and thorough documentation of necessary records is performed.
• Assist the Center Manager and/or Assistant Manager in any task necessary in pursuit of company objectives.

Operations Supervisor

• Maintain the ability to perform any/all tasks within the plasma center; fulfill the role of production employees and supervise donor flow
• Learn and maintain thorough familiarity and compliance with all state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP) and internal company procedures
• Supervise donor selection, plasma collection and all manufacturing records to maintain the highest production standards
• Submit timely and accurate reports as required by the Center Manager and/or the Assistant Manager
• Assist in the control of center donor funds as determined by the Center Manager and/or the Assistant Manager
• Assist in the training of new employees and retraining of current employees

• Maintain the ability to perform any/all tasks within the plasma center; fulfill the role of production employees and supervise donor flow.
• Learn and maintain thorough familiarity and compliance with all state and federal regulations.
• Supervise donor selection, plasma collection and all manufacturing records.
• Attend all required training sessions, staff meetings, etc.
• Ensure that accurate and thorough documentation is performed.
• Assure facility is maintained in a neat and clean condition and all equipment is kept in good working order.
• Submit timely and accurate reports as required.
• Assist in the training of new employees and retraining of current employees.
• Build rapport with donors.
• Report all unsafe situations or conditions to area lead.

Manager

• Responsible for meeting quarterly goals, staffing/hours per labor efficiency standards/cost per liter (CPL) targets and Quality key performance indicators (KPI) goals.
• Create appropriate organizational environment and value systems which stimulate the morale and productivity of the work force and its leadership.
• Operates the center and manages employees and operations to the highest standard of ethics and integrity.
• Manages staff to ensure that training and quality goals are met and to implement operational changes and maximize center efficiency.
• Monitor and evaluate operations. Develop action plans to maximize center efficiency and supervise the implementation of process improvements.
• Manages headcount to provide for efficient staffing through high and low production intervals, providing accurate and timely projections to reg management team in advance of cyclical and seasonal or situational spikes.
• Accountable for the direction of all personnel functions including hiring, assignment and direction of work, development and training, disciplinary actions and termination and the maintenance of all personnel records.
• Provides strategic direction and planning.

Center Manager

QA Automation Engineer

• Use technology to improve and streamline manufacturing processes through automation
• Collaborate with other automation engineers
• Act as a technical expert providing support for systems like DCS, PLC, SCADA, BAS

Automation Engineer I/II, Senior Automation Engineer I/II, Principal Automation Engineer

• Supervises a team of Quality Audit Specialists
• Oversees activities required to ensure center inspection readiness and compliance with regulations
• Coordinates final responses to regulatory inspections/audits
• Manages activities of Quality Audit Specialists
• Oversees Site Master Files preparation and maintenance
• Interacts with Regulatory Agencies as needed
• Writes/revises Change Requests, SOPs, or other documents as needed

Manager, Quality Audits

Risk

• Supervises a team of Quality Risk specialists.
• Ensures organizational adherence to corporate quality processes.
• Collaborates with corporate functional areas.
• Maintains oversight of all Quality Risk Management processes and Quality Assurance KPI metrics.
• Responsible for ensuring key stakeholders are aware of identified risks.
• Works closely with senior management to understand donor center and corporate quality data.
• Tracks and trends inspection/audit observations.
• Analyzes data and offers solutions to enhance compliance.
• Manages Corporate Deviation Reporting for Plasma Procurement.

Manager, Quality Risk

QA Engineer

• Quality assurance in the donation center: monitoring and ensuring compliance with quality standards within regulatory requirements
• Administrative support within the facility and center-wide organizational tasks
• Responsibilities include, among others, operational organization, quality assurance and administrative management, including inventory and ordering
• Responding to enquiries from the Human Resources department
• Supporting the Head of Production

Commercial Assistant, Quality Assurance

Technical Project Manager

• Responsible for managing various facets of quality projects related to submissions to the FDA, review and approval of documents and the management of systems.
• Develop production objectives, manage, and maintain project plans
• Interface with various groups to ensure that objectives and timelines are met specifically for preparing complex technical submissions related to major facility projects
• Review and approve protocols and final reports
• Ensure implementation and maintain compliance of Methods Validation
• Write and revise documents and procedures
• Plan, direct and manage internal and contract manufacturing projects from concept to production using recognized project management tools including initiation, control and closure.
• Formulate project objectives, approaches, schedules, risk assessments, budgetary constraints and manpower requirements in accordance with customer needs.
• Lead cross-functional project team on project execution to meet objectives, on-time delivery and budget constraints
• Establish and maintain timely and clear communication with project team, customers and suppliers.
• Ensure appropriate processes are followed for effective and timely engagement of related parties in completion of designated project activities.
• Provide regular status update to senior management.