Grifols

Compliance

• Responsible for the execution of a variety of compliance requirements within the Quality Management System (QMS) of the site
• Provide Reports to site in relation to Quality Management System (QMS) as required
• Provide regular reports on site’s metrics to appropriate management
• Quality system integration
• Data Integrity system
• Applicable training requirements (i.e. GMP introductory and refresher training)
• Quality Risk Management
• Supplier management system
• Support the completion and execution of Site Quality Council and Annual Product Reports
• Communicate with cross functional departments sites’ compliance and quality systems issues
• Supporting or Conducting audits of suppliers/outsourced providers, where applicable
• Supporting the coordination of self-inspection system in GWWO, where applicable
• Provide support ensuring external audit readiness and during external audits and corporate internal audits
• Ensures the corrections of findings, risks and recommendations are promptly and thoroughly incorporated into the quality systems
• Identifies and shares "Best Practices"
• Participate in investigations of quality system issues and drives CAPA implementation to ensure CAPA findings, risks, recommendations, and outcomes are appropriate and are clearly documented and communicated
• Trends, analyses, and reports on quality data to improve product and process Quality; develop recommendations based on data analyses
• Managing and coordinating Supplier qualification process, supplier complaints, and supplier agreements
• Other activities related to QMS

Quality Compliance Specialist – 12 Month FTC

Phlebotomist

• Assist in determining the suitability of donors
• Establish rapport with donors to ensure overall customer happiness
• Respond to and assist with handling donor reactions
• Monitor donor and equipment to ensure health of donors and quality of product
• Set up, disconnect, and operate the automated plasmapheresis machines
• Disconnect and dispose of all contaminated disposable equipment

• Assist in determining the suitability of donors.
• Establish rapport with donors to ensure overall customer happiness while ensuring donor confidentiality.
• Respond to and assist with handling donor reactions.
• Monitor donor and equipment to ensure health of donors and quality of product.
• Set up, disconnect, and operate the automated plasmapheresis machines.
• Disconnect and dispose of all contaminated disposable equipment.

Technician

• Conducts pre-donation medical screening.
• Interaction and responsiveness to customer needs.
• Assesses donor suitability and engages in set-up.
• Provides appropriate feedback to ineligible donor candidates.
• Ensures all donor screening information is complete.
• Ensures donor confidentiality.

Donor Center Technician

General

• 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

LPN, LVN, RN

• Gestionar y ejecutar los proyectos de validación asignados de acuerdo a la normativa vigente con el objetivo de asegurar la validez de los procesos productivos.
• Realizarás la redacción, revisión y aprobación de protocolos e informes de cualificación.
• Realizarás la redacción, revisión y aprobación de protocolos e informes de validación.
• Ejecutarás estudios de cualificación y validación.
• Actualizarás los protocolos de validación a la normativa vigente.
• Editarás las desviaciones, seguimiento de CAPAs y valoración de controles de cambios.

Validation Specialist

• Lead and manage the site Data Integrity Programme, including SOP governance, compliance assessments, risk management activities, and site-wide data integrity initiatives.
• Support the implementation and continuous improvement of the Grifols Quality Systems & Compliance Programme.
• Ensure compliance with corporate, regulatory, and site requirements.
• Identify compliance risks and recommend improvements to quality systems and processes.
• Manage and coordinate key Quality Systems including: Change Control, Deviations, Corrective and Preventive Actions (CAPA), Supplier Quality Management, Supplier Complaints and Supplier Agreements, Documentation Control, Training Compliance, Quality SAP Processes, Other Quality System activities as required.
• Support compliance activities across the site, including variation submissions, product specification compliance, new product introductions, and implementation of new manufacturing processes.
• Support site readiness for regulatory inspections, customer audits, and corporate audits.
• Coordinate and ensure timely completion of corrective actions arising from audits, inspections, and compliance assessments.
• Participate in investigations of quality system issues and drive effective CAPA implementation.
• Manage the Documentation Compliance Management (DCM) system.
• Oversee QMS document archives and records management activities.
• Generate and communicate site Quality System metrics and compliance reports.
• Support Site Quality Council activities and Annual Product Review processes.
• Analyse and trend quality data to identify opportunities for continuous improvement.
• Support supplier qualification programmes and supplier quality activities.
• Conduct or support supplier and outsourced provider audits as required.
• Coordinate site self-inspection programmes and follow-up activities.
• Support external audit preparation and facilitate audit activities.
• Partner with Manufacturing, Engineering, Supply Chain, Quality Control, Regulatory Affairs, and other functional groups to resolve quality and compliance issues.
• Communicate quality and compliance requirements across the site.
• Identify and share best practices within the organisation and across Grifols manufacturing sites.
• Deliver or coordinate GMP and quality system training where required.
• Lead, coach, and develop Quality Systems & Compliance personnel.
• Foster a culture of accountability, engagement, collaboration, and continuous improvement.

Quality Systems, Compliance Manager

EMT-B, EMT-A – Part Time

Processor

• Collects and processes donor samples for processing and testing.
• Records weight of product and samples.
• Labels samples and freezes units for final packing within required timeframe.
• Packs units for final shipment; packs samples and prepares shipping box to send samples to the testing lab.
• Monitors stored products and reports working conditions of equipment.
• Maintains active communication and quality.

Plasma Processor

Manager

• 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
• Creates 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
• Develops action plans to maximize center efficiency and supervises the implementation of process improvements
• Provides strategic direction and planning.

Grifols

Quality Compliance Specialist – 12 Month FTC

Phlebotomist

Phlebotomist

Phlebotomist

Donor Center Technician

LPN, LVN, RN

Validation Specialist

Quality Systems, Compliance Manager

Phlebotomist

EMT-B, EMT-A – Part Time

Plasma Processor

Center Manager – Plasma Donation

EMT / Paramedic

LPN / LVN

Plasma Processor