Grifols

Operations

• Overseeing the daily activities of donor floor operations
• Supervising staff and supporting compliance with regulatory and quality standards
• Serving as acting leader in the absence of the Center Manager
• Monitoring donor flow
• Compiling and submitting orders to vendors
• Ensuring accurate documentation of necessary records
• Leading by example in promoting a culture of safety, teamwork, and accountability

Senior 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
• Supervise donor selection, plasma collection, and all manufacturing records
• Attend all required training sessions, staff meetings, etc.
• Ensure documentation of necessary records is performed accurately
• Assist in training new employees and retraining of current employees

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 in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP
• Attend all required training sessions, staff meetings, etc
• Ensures that accurate and thorough documentation of necessary records is performed
• Under the guidance of the Center Manager and/or the Assistant Manager, 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 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
• Maintains active communication with other service areas to ensure accurate documentation and quality
• Builds rapport with donors to ensure overall customer satisfaction with the center to support long-term donation
• Reports all unsafe situations or conditions to area lead, supervisor or manager

Manager

• Drive the implementation and operational readiness of Quality functions at new Biopharma manufacturing facilities across the EU, US, Canada, and other global locations.
• Lead cross-functional quality teams, including Subject Matter Experts (SMEs), and collaborate closely with Engineering, Manufacturing, Regulatory Affairs, IT, and Global Quality.
• Implement site-specific quality strategies, ensuring alignment with global policies and regulatory cGMP requirements (FDA, EMA, Health Canada, etc.).
• Ensure readiness for regulatory inspections through comprehensive planning, mock audits, and gap assessments.
• Conduct practice sessions with key site personnel to have successful interactions with regulatory inspectors.

Senior Manager – Quality Operational Readiness

• Acts as the general manager for a Plasma Collection Center and has overall responsibility for the center's operation.
• Works under general occasional guidance and general oversight of regional management.
• Manages the daily operations of the center, supervising operations and quality control, and ensuring compliance with all applicable policies and regulations.
• 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.
• Directs and manages employees.
• 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 regional 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 – Plasma Donation Center

• Acts as the general manager for a Plasma Collection Center and has overall responsibility for the center's operation.
• Works under general occasional guidance and general oversight of regional management.
• Manages the daily operations of the center, supervising operations and quality control, and ensuring compliance with all applicable policies and regulations.
• 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.
• Monitors and evaluates operations.
• Develops action plans to maximize center efficiency and supervises the implementation of process improvements.
• Provides strategic direction and planning.
• Maintains thorough familiarity and ensures compliance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP).

• 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 in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP.
• Submit timely and accurate reports as required by the Center Manager and/or the Assistant Manager.
• Assist in the training of new employees and retraining of current employees.
• Maintains active communication with other service areas to ensure accurate documentation and quality.

• 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 in accordance with Federal and State regulations
• Attend all required training sessions, staff meetings, etc.
• Ensure that accurate and thorough documentation of necessary records 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 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
• Maintains active communication with other service areas to ensure accurate documentation and quality
• Builds rapport with donors to ensure overall customer satisfaction with the center to support long-term donation
• Reports all unsafe situations or conditions to area lead, supervisor or manager

• Lead the Business Optimization Analytical Hub team.
• Establish rigorous performance measurement standards and create advanced financial models to forecast value.
• Perform quantitative analysis to validate and track results from Continuous Improvement efforts and key Plasma Projects.
• Develop robust business cases and financial models for project impacts.
• Collaborate with Finance, Operations and Strategy teams for alignment and accuracy.

Senior Manager, Business Performance & Value

• Evaluates processes and develops action plans
• Maintains oversight of the center's quality management system
• Directs and monitors processes for compliance with regulations
• Implements Standard Operating Procedures (SOPs) for quality control
• Collaborates with Center Manager to ensure product quality
• Prepares quality analysis reports to track issues and set goals

Plasma Center Quality Manager

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 / EMTA, Paramedic - Bilingual in Spanish

• 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 including 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 Assoc(s); including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of all.
• 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.
• 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.
• Directs the maintenance and calibration of equipment and documentation of procedures.
• Ensures that Clinical Lab 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.
• 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.

Quality Manager

• Lead the delivery of end-user services across L0, L1, and L2, ensuring issues are appropriately deflected, resolved, or escalated based on defined support models
• Strengthen self-service capabilities by improving knowledge quality, usability, and accessibility, and identifying opportunities to reduce ticket volume through automation and better user guidance
• Ensure the service desk operates as a consistent global point of contact, with effective triage, improved first-contact resolution, and adherence to service levels
• Monitor ticket queues, backlog, and response performance, taking action to maintain stability and improve responsiveness
• Drive consistency across support channels (portal, chat, phone, email), ensuring a seamless and reliable user experience
• Oversee deskside and field support activities, ensuring timely resolution of complex, onsite, and hardware-related issues, including device lifecycle coordination
• Support effective coordination with vendors and field service providers, ensuring services are delivered to expected quality and timelines
• Use operational data and user feedback (CSAT/CES) to identify trends, recurring issues, and opportunities to improve service delivery
• Partner with platform and automation teams to translate operational needs into workflow improvements, automation, and enhanced self-service capabilities
• Reinforce standardized processes and ways of working across regions, improving consistency and reducing variability in service delivery
• Ensure support activities are properly documented and aligned with compliance and control requirements
• Lead and develop Delivery Managers and support teams, establishing clear expectations, accountability, and a focus on service excellence

Senior Manager, Digital Technology Services

• Oversee the establishment and implementation of manufacturing and quality policies
• Ensure the compliance with the FDA and/or EC, if applicable
• Propose and manage budgets and investments of Bio Supplies Manufacturing site departments
• Lead staff meetings to update and direct senior management
• Participate in regulatory and internal inspections/audits
• Maintain current knowledge of regulatory and industry standards
• Supervise the Manufacturing site Operations Management team
• Establish strategic plans and objectives with senior management

Director of Operations, Bio Supplies Manufacturing

• Providing support to the Technical Director to ensure compliance of the Quality Operations, Regulatory and cGMP Compliance Program of Grifols USA.
• Generates records to comply with regulatory requirements, (cGMP QSR/FDA Quality Standards, Good Distribution Practices and Internal Quality Standard Operating Procedures) within the organization.
• The position ensures that the quality systems are in compliance with the rules and regulations of the regulatory agencies (FDA 21 CFR, PIC/S GDP) and that the company policies and procedures are being followed.
• Manages the customers of the distributed BioPharma products to ensure compliance to Good Distribution Practices. This includes qualification and requalification via risk analysis, desk audit or on-site audit.
• Works alongside Managed Markets to ensure the distributors of the BioPharma products have an established and current quality agreement.
• Tracks the shipping complaints associated with the distribution of BioPharma and HealthCare Solutions product to ensure they are appropriately reported, recorded and resolved on a timely basis.
• Creates and updates procedures to ensure the respective departments associated with the distribution of product are appropriately incorporated under the GUSA Quality System. This includes BioPharma and HealthCare Solutions.
• Serves as the Training Coordinator (GTP and Manual Training) to establish the Training Profiles of new GUSA employees and distribute and manage the training responsibilities that must be processed manually for GUSA personnel.
• Responsible for the review and record keeping of GUSA's Quality Systems records: CAPA, deviation, Complaints, Returns, Inventory Control, review and closure of HealthCare Solutions Hospital Call Center Service Cases.
• Assists Technical Director in ensuring the GUSA's Quality System are compliant to the applicable regulations.
• Works with HealthCare Solutions Customer Service to ensure suppliers/product/materials are reviewed for Regulatory Requirements by Global Marketing and approved by GUSA for distribution within the United States prior to issuing an SAP Code.
• Performs Internal Audits to ensure that the GUSA Quality Systems are compliant to Good Distribution Practices.
• Performs Supplier Audits to ensure that the product being supplied to GUSA for distribution within the United States meets the US Regulatory Requirements.
• Maintains the Approved Supplier List for GUSA.