Grifols

Associate

• Perform quality assurance and training functions to ensure compliance with internal and external regulations and protocol
• Completes weekly review of equipment QC and maintenance records
• Documents, investigates, and performs root-cause analysis for deviations and customer complaints
• Inspects and releases incoming supplies
• Performs documentation review for unsuitable test results
• Assists the Quality Systems Manager to ensure cGMP regulation, SOPs and regulatory requirements are followed
• Creates, maintains, and audits training records and files to ensure compliance
• Conduct employee training observations
• Reviews lookback information and documentation
• Conducts training to address donor center corrective and preventive measures

Quality Systems Associate

Operations

• 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)
• Monitors and evaluates 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
• Directs and supervises employees, including creating and managing work schedules
• Establishes and maintains the ability to perform all tasks within the center; fulfills the role of production employees when the occasional need arises
• Assures center employees maintain the facility in a neat and clean condition and all equipment is kept in good working order
• Responsible for freezer management, including overseeing plasma shipments and equipment failures
• Required to answer all freezer alarms and deal with them appropriately
• Develops and implements active donor recruitment advertising campaigns to improve production levels
• 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)
• Directs key personnel in donor selection, plasma collection and all manufacturing records to maintain the highest production standards

Operations Manager

Phlebotomist

• Assists in determining the suitability of donors to undergo plasmapheresis prior to venipuncture.
• Responds to and assists with handling donor reactions in accordance with guidelines.
• Monitors donor and equipment to ensure health of donors and quality of product.
• Sets up, disconnects and operates the automated plasmapheresis machines including response and evaluation of all autopheresis troubleshooting displays, documentation of exceptions, etc.
• Ensures the proper calibration and maintenance of autopheresis machines and associated equipment.
• May be trained to repair plasma equipment.
• Disconnects and disposes of all contaminated disposable equipment.
• Ensures proper cleaning of equipment and work area between donors.
• Maintains accurate and thorough documentation of production records.
• Ensures donor confidentiality.
• Builds rapport with donors to ensure overall customer satisfaction with the center to support long-term donation.
• Learns and maintains thorough familiarity and compliance with all state and federal regulations, 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.
• Reports all unsafe situations or conditions to area lead, supervisor or manager.

Lead Phlebotomist

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

• Collects and processes donor samples for processing and testing
• Records weight of product and samples
• Labels samples and freezes units for final packing
• Packs units for final shipment
• Monitors stored products and reports working conditions of equipment
• Maintains active communication and quality

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

Center Medical Specialist – EMT, Paramedic, LPN/LVN

Supply Chain

• Supervise the receipt, handling, verification, storage, and distribution of plasma to ensure compliance, safety, and adherence to procedures as defined by Standard Operating Procedures (SOPs), cGMP, and OSHA standards.
• Ensure that each plasma shipment, production unit, and batch meets all applicable quality, storage, and production requirements, and that each plasma batch is delivered in a timely manner to the appropriate customers.
• Ensure that any individual unit of plasma deemed nonconforming for further processing is removed, inventoried, and handled in accordance with documented procedures.
• Participate in recruiting, hiring, and training, and directly supervise employees in the Plasma Operations group.
• Monitor performance, labor relations, and quality standards to maintain team effectiveness.
• Develop and maintain departmental SOPs in accordance with regulatory and company requirements.
• Ensure procedures accurately reflect current processes.
• Coordinate and oversee all inventory transactions related to the storage and movement of raw plasma.
• Maintain inventory accuracy levels in accordance with established targets.
• Collaborate with numerous internal and external stakeholders, including production, carriers/transport providers, Quality Operations, and various other groups, on a range of issues.
• Work closely with the Quality Operations group to assess incoming plasma to determine whether it is acceptable, nonconforming, or exhibits deviations.
• Support department management in preparing the annual budget and in monthly tracking of expenditures against budgeted line items.
• Assist management in ensuring that appropriate resources (personnel, equipment, and supplies) are budgeted and allocated to meet processing requirements.

Sr. Supervisor, Plasma Supply Chain

Center Medical Specialist – EMT or Paramedic

Center Medical Specialist, LPN/LVN

• 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.

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

• 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

• 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 donor confidentiality.

Quality Systems Associate

Operations Manager

Lead Phlebotomist

Plasma Processor

Plasma Processor

Center Medical Specialist – EMT, Paramedic, LPN/LVN

Sr. Supervisor, Plasma Supply Chain

Center Medical Specialist – EMT or Paramedic

Center Medical Specialist, LPN/LVN

Plasma Processor

Donor Center Technician

Donor Center Technician

Donor Center Technician

LPN/LVN, RN

Plasma Processor