Grifols

Operations

• 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.
• May be trained to repair plasma center equipment.
• 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
• Supervise donor flow and ensure accurate and thorough documentation of records
• Attend all required training sessions and staff meetings
• Submit timely and accurate reports as required by the Center Manager and/or the Assistant Manager
• Assist in the control of center donor funds
• Build rapport with donors to ensure overall customer satisfaction
• Report all unsafe situations or conditions to area lead, supervisor or manager

• 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
• Ensure 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
• Maintain active communication with other service areas to ensure accurate documentation and quality
• Build rapport with donors to ensure overall customer satisfaction with the center to support long-term donation
• Report all unsafe situations or conditions to area lead, supervisor or manager
• May be trained to repair plasma center equipment
• Assist the Center Manager and/or Assistant Manager in any task necessary in pursuit of company objectives

Compliance

• Implement worldwide regulatory product registration strategies, prepare complex registration dossiers, establish and maintain tracking of product registrations to determine what products can be shipped to intended markets in accordance with business plan with a specific focus on labeling, labeling requirements, and implementation.
• Coordinate and submit all regulatory documentation for establishment of new / changed local market authorization holders and distributors.
• Analyze and determine worldwide product registration requirements for specific assigned products and regions.
• Communicate and negotiate with local market authorization holders/ distributors / regulatory authorities the information required and prepare regulatory submissions to be used worldwide for all marketed products.
• Prepare responses to regulatory agency inquiries.
• Coordinate with local authorities and Quality standards and controls required for product registration testing.
• Prepare personnel from affiliates or third parties for meetings with regulatory authorities.

Manager/Sr. Manager, Regulatory Affairs – Labeling

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

EMT, Bilingual in Spanish

Mechanical Engineer

• Contribute to system design on utility systems.
• Help develop construction documents for plumbing systems.
• Specify utility equipment and modify existing specifications.
• Supervise contractors during construction.
• Analyze existing utility systems for new operations.
• Work towards subject matter expertise in industrial utility design.

Utility Design Engineer

QA Engineer

• Applies risk-based approach for creation and execution of the annual supplier audit program, providing guidance to the team for the successful completion.
• Develops and executes qualification program for new materials and suppliers using risk-based approach.
• Defines and monitors supplier risk-level by evaluating material using the supplier risk-tool and ensures that the supplier and material meets Grifols requirements.
• Provides rationale for the supplier status event report and ensures the appropriate actions were addressed and are timely completed.
• Ensures the appropriate Vendor Notification process is established and the communication of nonconformances (SCAR) to suppliers is maintained.
• Provides technical assessment on the effectiveness of resolutions of Supplier issues.
• Lead internal investigations to appropriately define root-cause of Low, Medium and High-risk material and supplier related issues.
• Applies appropriate statistical methods to effectively create the corrective and preventive plans.
• Ensures on-time and appropriate closure of supplier actions (SCAR).
• Reviews, approves and monitors the Supplier Qualification and Performance (scorecard).

Senior Supplier Quality Engineer – Injection Molding

• Plays a critical leadership role in the day-to-day operations of the plasma donor center
• Oversees daily activities of donor floor operations and supervises staff
• Supports compliance with regulatory and quality standards
• Acts as a lead resource during shifts
• Ensures execution of operational priorities
• Provides direct support to the Center Manager in driving performance and donor satisfaction
• Monitors donor flow and proactively addresses delays or service issues
• Ensures accurate and thorough documentation of necessary records
• Participates in onboarding, training, and cross-training of staff

Senior Operations Supervisor – Plasma Center

Field Engineer

• Responsible for customer relationship management by responding to clients within designated timeframes regarding inquiries, complaints, service calls and site evaluations on instrumentation.
• Independently manages schedules including travel arrangements, appointments at client site and coordination of order and delivery of parts.
• Coordinates and executes hardware upgrades and regulatory documents associated with client site.
• Collaborates with project team and performs software upgrades and product installations including installation, operational and performance qualifications.
• Ensures proper transition of project timeline to Technical Application Team.
• Proactively and independently manages ongoing preventive maintenance calls per manufactures requirements including scheduling with client, documenting and attaching work in CRM per regulatory guidelines within designated timeframes.

Field Service Engineer

• Maintain the ability to perform any/all tasks within the plasma center
• Supervise donor selection, plasma collection and all manufacturing records
• Attend all required training sessions, staff meetings, etc.
• Ensure accurate documentation of necessary records
• Assist in training of new employees and retraining of current employees

• Responsible for all aspects of the donor center when the Center Manager is not present.
• Collaborates with Training and Quality staff to ensure that training and quality goals are met.
• Coaches and leads through effective feedback to employees through the Operations Supervisor(s).
• Monitor and evaluate operations.
• Works with the Center Manager to develop action plans to maximize center efficiency and supervises the implementation of improvements.
• Makes critical decisions for the modifications of action plans.
• Responsible for all personnel functions including hiring, assignment and direction of work, development and training, disciplinary actions and termination and the maintenance of all personnel records.
• Partners with the Center Manager in budget preparation and oversees facility to achieve production targets and quality goals at the agreed-upon cost structure.
• Actively delegates, monitors, and holds responsible the operations supervisors for their performance.

Operations Manager – Plasma Center

Content Marketing Manager

• Project lifecycle management, including Participate in assessments of new project requests
• Project management and schedule management
• Work closely with Web Development teams to enable the delivery of technical facets associated with projects that will enhance customer and brand experience
• Recommending digital marketing and experience solutions for websites and apps for the brand and product teams and integrating all solutions to fit into an overall marketing campaign
• Develop a deep understanding of stakeholders’ strategic objectives and problems to solve in close alignment with the Project Management Liaison (PML)
• Website content editing
• Partner with PML & stakeholders to get briefed on overall objectives and problems to scope projects, including functional requirements as well as dependencies, schedules, and budgets
• Recommend digital tactics as part of an integrated digital marketing communication plan (independently or together with agencies) to support brand strategies
• Develops clear, integrated campaigns and executes digital tactics and traditional channel projects as assigned. (Focus is on digital)
• Collaborate with PML & stakeholders in the various segments of projects to ensure it can be project managed effectively and on time
• Execute on the areas of subject matter expertise and assigned projects
• Understand the important metrics associated with area of subject matter expertise and assigned projects, to set KPI targets aligned to overall CEE and industry benchmarks
• Collaborate with internal teams to ensure that all components of the measurement plan are in place so that the campaigns and projects can be measured and presented against their prior agreed KPIs, including analytics and reporting for digital activities
• Continuously advise on optimizations and improvement processes to enhance the overall delivery of solutions
• Build rapport and partnership with various internal cross-functional groups (e.g., Marketing, IT, legal, regulatory) to provide scalable enterprise solutions when the business needs requires
• Supports and contributes to advancements in digital capabilities within the company and participates in the evaluation of new vendor/technologies as requested

Digital Content, Web Specialist

• Evaluate materials and suppliers in accordance with established procedures.
• Ensure materials comply with specifications, regulatory requirements, and internal standards.
• Produce and review product evaluation reports.
• Conduct annual evaluations of qualified suppliers based on quality, compliance, and performance criteria.
• Participate in risk assessments related to materials and suppliers.
• Maintain the list of approved suppliers and ensure their ongoing compliance.
• May participate in internal audits and supplier audits.
• Provide support for regulatory inspections and customer audits, as required.
• Support the management and continuous improvement of systems, programs, or projects related to quality.
• Ensure compliance with company policies and procedures within the scope of expertise.
• Provide technical guidance on quality and compliance matters.
• Collaborate with manufacturing, regulatory, and production teams on GxP-related issues.
• Adhere to Good Manufacturing Practices (GMP) and departmental safety procedures.
• Assist in preparing proposals and recommendations for department management.
• May investigate and resolve quality issues related to materials and suppliers.
• Draft and review SOPs and other quality documents related to materials and suppliers.
• Collaborate with production, quality control, and other departments on projects, deviation investigations, CAPA, change controls, and quality system improvements.

Quality System & Compliance Specialist

EMT – Advanced or Paramedic, Bilingual in Spanish

• Implement worldwide regulatory product registration strategies.
• Prepare complex registration dossiers.
• Analyze and determine worldwide product registration requirements.

Operations Supervisor

Operations Supervisor

Operations Supervisor

Manager/Sr. Manager, Regulatory Affairs – Labeling

EMT, Bilingual in Spanish

Utility Design Engineer

Senior Supplier Quality Engineer – Injection Molding

Senior Operations Supervisor – Plasma Center

Field Service Engineer

Operations Supervisor

Operations Manager – Plasma Center

Digital Content, Web Specialist

Quality System & Compliance Specialist

EMT – Advanced or Paramedic, Bilingual in Spanish

Senior Regulatory Affairs Specialist II/Manager 1