Grifols

Nurse

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

LPN, LVN

Operations

• Serve as acting leader in the Center Manager’s absence when assigned
• Perform any/all plasma-center tasks, including production-employee duties and donor-flow supervision
• Oversee donor operations and supervise operation supervisors and donor-center staff during assigned shifts
• Coordinate staffing, task assignments, break schedules, and coaching
• Create employee schedules to accommodate donor cycles
• Monitor and adjust inventory levels and submit vendor orders
• Inform the Center Manager of irregularities and provide corrective action plans
• Execute daily operational plans to achieve donor throughput, quality, and productivity targets
• Partner with the Center Manager and Quality team to resolve deviations and operational concerns
• Monitor donor flow and address delays or service issues
• Maintain compliance with state and federal regulations, FDA-approved SOPs, OSHA, CLIA, cGMP, and company procedures
• Supervise donor selection, plasma collection, and manufacturing records
• Attend required training sessions and staff meetings
• Ensure accurate and thorough documentation
• Maintain facility cleanliness and equipment condition
• Submit timely and accurate reports
• Assist with control of center donor funds
• Participate in onboarding, training, and cross-training staff
• Maintain communication with other service areas to ensure documentation and quality
• Promote safety, teamwork, and accountability
• Report unsafe situations or conditions
• May be trained to repair plasma-center equipment
• Assist the Center Manager with tasks supporting company objectives

Plasma Center Operations Supervisor

Technician

• Collect environmental monitoring samples in manufacturing processing areas, including viable, non-viable, surface, personnel, water and gases
• Prepare equipment and supplies required for environmental monitoring
• Share responsibilities for monitoring equipment maintenance and calibration
• Perform housekeeping and support functions, including inventory of consumables and reagents
• Compile and enter data into SAP for reporting and trending
• Review test results against specifications
• Maintain daily sample logs for timely testing and sample tracking
• Maintain instrument usage and calibration logs
• Follow procedures and practices according to FDA regulations
• Maintain strong documentation according to FDA regulations
• Adhere to departmental and corporate safety policies

Environmental Monitoring Technician

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

LPN/RN

• Perform physical examinations and establish medical histories to determine donor suitability
• Build rapport with donors to ensure overall customer satisfaction
• Ensure donor and staff confidentiality
• Inform donors about potential hazards
• Provide donor education regarding general health
• Counsel donors regarding unacceptable test results
• Evaluate and manage donor injuries and adverse events
• Evaluate illness and medication histories to ensure continued donor suitability
• Assist in employee training
• Administer the employee Hepatitis Vaccine program

Registered Nurse – Bilingual in Spanish

QA Engineer

• Provide routine technical support for documentation, training, compliance, product release, scheduling, assignments, and projects
• Perform final container product release
• Perform batch-related activities and meet cycle-time release targets
• Collect, review, and potentially analyze data
• Make decisions within defined areas and resolve problems according to SOPs and established practices
• Supervise or train employees as needed
• Communicate effectively across all organizational levels
• Participate as author, reviewer, administrator, or coordinator in quality systems
• Provide Quality input for validation, capital engineering, clinical, stability, ETP, and regulatory projects or submissions
• For QA III, develop alternative solutions to complex problems and represent Quality at business-unit and project meetings

Quality Associate II/III, QA

• Set up, operate, and clean process equipment in a biologics processing environment for plasma-derived pharmaceuticals
• Separate, purify, fill, inspect, and package protein products
• Adhere strictly to procedures, FDA regulations, documentation requirements, and corporate safety policies
• Clean and sanitize aseptic and non-aseptic processing areas
• Prepare and sterilize filling and freeze-drying components, including vials, stoppers, and filling assemblies
• Perform aseptic fills
• May perform or receive training in freeze-drying (lyophilization)
• Use touchscreen Operator Interface Terminals (OIT)
• Adhere to production schedules and standards

Manufacturing Technician – IGIV Bulk

Associate

• Evaluate visual, dimensional, and functional critical quality attributes of quality-managed materials
• Coordinate required chemical and biological testing
• Execute approved usage and release decisions for quality-managed materials
• Issue and track Incidents/Raw Material Reports for discrepant material
• Quarantine discrepant product according to approved disposition procedures
• Stay current with changing regulatory-agency requirements
• Reconcile all released products, including labels, plasma, and raw material components
• Inspect final-container reserve samples according to approved procedures
• Perform packaging-area quality representative duties, including sampling, auditing, and quality decisions
• Audit final product batches using designated sampling plans
• Perform reserve sampling, post-pack identity sampling, packaging commodity verification and reconciliation, line-clearance verification, and stability-sample inspection
• Associate-level coordinators train new employees and serve as subject matter experts

Quality Associate – Materials Evaluation Coordinator

• Perform physical examinations and establish medical histories to determine donor suitability
• Build rapport with donors to ensure overall customer satisfaction
• Ensure donor and staff confidentiality
• Inform donors about potential hazards
• Provide donor education regarding general health and counsel donors regarding unacceptable test results
• Evaluate and manage donor injuries and adverse events
• Evaluate histories of illness or medications to ensure continued donor suitability
• Assist in employee training
• Administer the employee Hepatitis Vaccine program

Bilingual

• Perform physical examinations and establish medical history to determine donor suitability
• Build rapport with donors to ensure overall customer satisfaction
• Ensure donor and staff confidentiality
• Educate donors about potential hazards
• Provide donor education regarding general health and counsel donors regarding unacceptable test results
• Evaluate and manage donor injuries and adverse events
• Evaluate illness and medication histories to ensure continued donor suitability
• Assist in employee training
• Administer the employee Hepatitis Vaccine program

Bilingual EMT or LPN for Plasma Donation Center

Compliance

• Maintain Qualified Author status to author and revise documents according to governing SOPs
• Coordinate development, maintenance, review, routing, publishing, periodic reviews, and historical file management for BPRs, SOPs, and EBRs in the Document Management System and Aizon
• Review and evaluate documentation for compliance with cGMPs, cGDocPs, BLAs, regulatory requirements, and site quality standards
• Coordinate document processing for Risk Assessments, Manufacturing Methods, Project Plans, and related documents
• Execute changes to electronic batch record Master Recipes in Aizon
• Process periodic document reviews and distribute reviewer notifications before due dates
• Conduct instructor-led training classes for author qualifications
• Author, revise, review, route, and/or approve Change Control Requests, incident entries, and investigation reports
• Represent Quality Document Management in discussions and meetings with other business groups
• Collaborate with Manufacturing, Quality Assurance, Quality Control, Validation, and other departments on projects, investigations, CAPAs, change controls, and quality-system improvements
• Update document profiles and the Document Management System; generate, review, and post reports to Cosmos
• Assist with site regulatory inspections and customer audits
• Consult with management to develop and implement quality-related solutions
• Support deployment of technical resources toward annual goals
• Make independent decisions within defined responsibilities
• Lead or participate in multidisciplinary project teams and advance technical project proposals to senior management
• Collect and analyze data to generate overview reports
• Participate in internal and supplier compliance audits and failure investigations
• Perform other duties as assigned

Senior Quality Associate I, Quality Compliance

Assistant

• Perform environmental monitoring of fill lines in SFF and PFF
• Perform environmental monitoring of classified production areas
• Sample site utility systems
• Execute the Quality Oversight program for fill lines
• Provide quality control approval of on-site air flow visualizations
• Complete sampling and testing to maintain environmental monitoring and production areas in a state of control
• Support multiple filling activities during assigned shifts to avoid production delays
• Follow SOPs and oral instructions
• Maintain precise, legible, and organized documentation
• Perform assigned cleaning and housekeeping duties

Assistant Biologist

• Perform complex laboratory analysis of plasma and plasma products in a GMP laboratory
• Accession samples and prepare samples and reagents
• Conduct testing and calculate results
• Perform quality control of assays and equipment
• Support assay validation, method transfer, reagent qualification, and control qualification
• Perform laboratory maintenance activities as assigned
• Perform environmental monitoring of fill lines in B300 and SFF
• Perform environmental monitoring of classified production areas and sample site utility systems
• Execute the Quality Oversight program for fill lines
• Provide quality control approval of on-site air flow visualizations
• Support filling activities across shifts to avoid production delays and maintain environmental monitoring controls
• Perform tasks according to written SOPs and oral instructions

Assistant – Associate Biologist

• Provide routine technical support for documentation, training, compliance, product release, scheduling, assignments, and projects
• Collect, review, and potentially analyze data
• Make decisions within a well-defined area
• Address and resolve problems according to written procedures or practice
• Coordinate work assignments and training of other employees
• Develop alternative solutions to problems
• Apply technical knowledge and expertise to medium-complexity assignments
• Perform roles such as author, reviewer, administrator, or coordinator in quality systems including Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews
• Provide Quality input for validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and regulatory submissions
• Represent Quality at the business unit
• Communicate effectively at all levels while supporting department objectives and management decisions

Quality Associate II/III, QA – Packaging

• Serve as acting leader in the Center Manager’s absence when assigned
• Perform all tasks within the plasma center, including production employee duties and donor flow supervision
• Oversee donor operations and supervise Operations Supervisors and donor center staff during assigned shifts
• Coordinate staffing, task assignments, break schedules, and coaching
• Create employee schedules to accommodate donor cycles
• Determine inventory needs, adjust inventory levels, and submit vendor orders
• Inform the Center Manager of irregularities and provide corrective action plans
• Execute daily operational plans to achieve donor throughput, quality, and productivity targets
• Partner with the Center Manager and Quality team to resolve deviations and operational concerns
• Monitor donor flow and address delays or service issues
• Maintain compliance with state and federal regulations, FDA-approved SOPs, OSHA, CLIA, cGMP, and company procedures
• Supervise donor selection, plasma collection, and manufacturing records
• Attend required training sessions and staff meetings
• Ensure accurate and thorough documentation
• Help maintain facility cleanliness and equipment condition
• Submit timely and accurate reports
• Assist with control of center donor funds
• Participate in onboarding, training, and cross-training staff
• Maintain communication with other service areas
• Promote safety, teamwork, and accountability
• Report unsafe situations or conditions
• May be trained to repair plasma center equipment
• Assist the Center Manager with tasks supporting company objectives

LPN, LVN

Plasma Center Operations Supervisor

Environmental Monitoring Technician

LPN/RN

Registered Nurse – Bilingual in Spanish

Quality Associate II/III, QA

Manufacturing Technician – IGIV Bulk

Quality Associate – Materials Evaluation Coordinator

LPN/RN

Bilingual EMT or LPN for Plasma Donation Center

Senior Quality Associate I, Quality Compliance

Assistant Biologist

Assistant – Associate Biologist

Quality Associate II/III, QA – Packaging

Senior Operations Supervisor