Grifols

Processor

• Collect and process donor samples for processing and testing
• Record the weight of products and samples
• Label samples and freeze units within the required timeframe
• Pack units for final shipment
• Pack samples and prepare shipping boxes for the testing laboratory
• Monitor stored products
• Report equipment working conditions
• Maintain accurate donor files
• Handle shipping and inventory control
• Maintain active communication and quality

Plasma Processor

Phlebotomist

• Assist in determining donor suitability
• Establish rapport with donors to ensure customer happiness and maintain donor confidentiality
• Respond to and assist with handling donor reactions
• Monitor donors and equipment to ensure donor health and product quality
• Set up, disconnect, and operate automated plasmapheresis machines
• Disconnect and dispose of contaminated disposable equipment
• Work in a plasma center supporting Grifols’ plasma-derived medicines operations

Technician

• Set up, operate, and clean process equipment in a biologics processing environment for plasma-derived pharmaceuticals
• Follow procedures and practices according to FDA regulations
• Complete documentation according to FDA regulations
• Adhere to departmental and corporate safety policies
• Clean facilities and equipment
• 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 be trained in the freeze-drying (lyophilization) process
• Utilize touch-screen Operator Interface Terminals (OIT)
• Operate equipment used to separate, purify, fill, inspect, and package protein products

Manufacturing Technician – IGIV Bulk

• Set up, operate, and clean process equipment in a biologics processing environment for plasma-derived pharmaceuticals
• Follow procedures and practices according to FDA regulations
• Complete documentation according to FDA regulations
• Adhere to departmental 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 train in the freeze-drying (lyophilization) process
• Use touchscreen Operator Interface Terminals (OIT)
• Perform work in a clean-room manufacturing environment to separate, purify, fill, inspect, and package protein products

QA Engineer

• Serve as primary quality lead on cross-functional teams focused on new materials, supplier qualification and supplier changes
• Develop and update material specifications and ensure specifications are created and approved
• Apply a risk-based approach to create and execute the annual supplier audit program
• Develop and execute qualification programs for new materials and suppliers
• Define and monitor supplier risk levels
• Provide rationale for supplier status event reports and ensure actions are completed on time
• Establish Vendor Notification processes and maintain communication of supplier nonconformances (SCAR)
• Lead investigations, root-cause analysis and corrective and preventive actions for supplier issues
• Review, approve and monitor Supplier Qualification and Performance scorecards
• Assess and approve supplier quality documentation and improvement plans
• Develop and trend Supplier Quality System metrics
• Create, review and approve supplier quality procedures and documentation
• Assess quality agreements with suppliers
• Conduct and approve internal and external audits and finalize audit reports
• Author and technically assess raw-material specifications
• Lead critical-issue and stakeholder meetings, document minutes and follow up on actions
• Assess and approve supplier change notifications and monitor implementation
• Apply knowledge of plastics and injection molding to support qualification, assess manufacturing capabilities and troubleshoot quality issues
• Assess injection molding processes, materials, tooling and supplier controls
• Support quality-system and procedural training programs
• Host third-party audits from the FDA, notified bodies and business

Senior Supplier Quality Engineer

Operations

• Serve as acting leader in the Center Manager's absence
• 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
• 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 documentation and timely reports
• Maintain facility cleanliness and equipment condition
• 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 conditions
• May be trained to repair plasma center equipment
• Assist the Center Manager with tasks supporting company objectives

Plasma Center Operations Supervisor

• Collect and process donor samples for processing and testing
• Record product and sample weights
• Label samples and freeze units within the required timeframe
• Pack units for final shipment
• Pack samples and prepare shipping boxes for the testing laboratory
• Monitor stored products
• Report equipment working conditions
• Maintain accurate donor files
• Handle shipping and inventory control responsibilities
• Maintain active communication and quality

• Conduct pre-donation medical screening
• Interact with donors and respond to customer needs
• Assess donor suitability and engage in donor set-up
• Provide appropriate feedback to ineligible donor candidates
• Ensure all donor screening information is complete
• Ensure donor confidentiality
• Work in a plasma center serving Grifols’ plasma-derived medicines operations

Donor Center Technician

• Assist in determining the suitability of donors
• Establish rapport with donors to ensure customer happiness while maintaining donor confidentiality
• Respond to and assist with handling donor reactions
• Monitor donors and equipment to ensure donor health and product quality
• Set up, disconnect, and operate automated plasmapheresis machines
• Disconnect and dispose of contaminated disposable equipment
• Work in a plasma center producing plasma-derived medicines for patients

Manager

• Evaluate processes, develop action plans, and coordinate strategic implementation of system processes and corrective actions
• Perform independent quality inspection and control to ensure center compliance with quality standards and regulations
• Collaborate with Center Managers to ensure product quality, donor suitability, and donor safety
• Direct and monitor processes for compliance with state, federal, and company regulations
• Ensure Standard Operating Procedures are interpreted and implemented properly
• Interpret and implement processes, regulations, and SOPs for quality control and regulatory compliance
• Oversee internal and external audits, including documentation, responses, and corrective/preventive actions
• Assess and improve quality-system effectiveness through trend recognition, failure investigations, employee observation, and document review
• Manage Quality Systems Associate personnel functions, including work assignment, hiring, training, scheduling, performance actions, and records
• Oversee product and biohazard waste shipments, including labeling, documentation, and final shipment authorization
• Review unsuitable test results and associated dispositions
• Document, investigate, and perform root-cause analysis for deviations and customer complaints
• Track and trend quality incidents and report critical incidents and problematic trends
• Report compliance status to relevant parties
• Ensure donor-file accuracy and appropriate supply storage and quality compliance
• Direct equipment maintenance, calibration, and procedure documentation
• Ensure CLIA proficiency tests, complaint investigations, and training are documented
• Monitor training documentation and cGMP training completion
• Track corrective/preventive actions, system implementations, and process-improvement plans
• Ensure required QC checks are performed and acceptable
• Verify SOPs and forms are current
• Partner with the Center Manager on donor suitability and donor deferrals
• Prepare quality-analysis reports and research systemic compliance issues
• Build rapport with donors to support customer satisfaction and long-term donation
• Review deferred-donor reinstatements, lookback information, and medical incident reports
• Lead regional and divisional projects and initiatives

Plasma Center Quality Manager

• Assist in determining donor suitability
• Establish rapport with donors to ensure customer happiness while maintaining donor confidentiality
• Respond to and assist with handling donor reactions
• Monitor donors and equipment to ensure donor health and product quality
• Set up, disconnect, and operate automated plasmapheresis machines
• Disconnect and dispose of contaminated disposable equipment
• Work in a plasma center producing plasma-derived medicines for patients

• Assist in determining donor suitability
• Establish rapport with donors to ensure customer happiness and confidentiality
• Respond to and assist with donor reactions
• Monitor donors and equipment to ensure donor health and product quality
• Set up, disconnect, and operate automated plasmapheresis machines
• Disconnect and dispose of contaminated disposable equipment
• Work in a plasma center while following required personal protective equipment procedures

• Assist in determining donor suitability
• Establish rapport with donors to ensure customer happiness while maintaining donor confidentiality
• Respond to and assist with handling donor reactions
• Monitor donors and equipment to ensure donor health and product quality
• Set up, disconnect, and operate automated plasmapheresis machines
• Disconnect and dispose of contaminated disposable equipment
• Work in a plasma center supporting the production of plasma-derived medicines

Nurse

• 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
• Raise donor awareness of 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 with employee training
• Administer the employee Hepatitis Vaccine program

EMT, PARA, LPN/LVN, RN

• 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
• 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 with employee training
• Administer the employee Hepatitis Vaccine program

Plasma Processor

Phlebotomist

Manufacturing Technician – IGIV Bulk

Manufacturing Technician – IGIV Bulk

Senior Supplier Quality Engineer

Plasma Center Operations Supervisor

Plasma Processor

Donor Center Technician

Phlebotomist

Plasma Center Quality Manager

Phlebotomist

Phlebotomist

Phlebotomist

EMT, PARA, LPN/LVN, RN

LPN/RN