Grifols

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

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

Phlebotomist

• 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.
• Monitors donor and equipment to ensure health of donors and quality of product.
• Sets up, disconnects, and operates the automated plasmapheresis machines.
• Disconnects and disposes 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

QA Engineer

• Provide routine technical support for various tasks (i.e. documentation, training, compliance, product release, scheduling, etc.)
• Collect, review, and analyze data
• Make decisions independently
• Address and resolve problems according to written procedure
• Communicate effectively and promptly at all levels of the organization
• Follow cGMP and department safety practices
• May supervise or train employees

Quality Associate II/III, QA, Final Container Release

• The Purification Technician performs fundamental tasks within a GMP environment by cleaning and maintaining the workplace, cleaning, assembling and disassembling operating equipment per applicable procedures, assisting with process control manipulations and maintaining records/logs in accordance with current standard procedures.
• Level I: Performs general housekeeping in compliance with the high standards required of a pharmaceutical operation.
• Dispenses and prepares necessary cleaning/sanitization reagents to clean and sanitize production areas.
• Assembles, disassembles, cleans and sterilizes production equipment (i.e. filters, tanks, etc.).
• Operates production equipment (i.e. centrifuge, ultra filtration units, columns, autoclaves, pasteurizers, etc.).
• Operates fork truck in a safe and efficient manner.
• Performs bulk processing and filtration involving processing parameters (i.e. pH, weights, suspension, etc.).
• Prepares buffer solutions and properly stores process intermediates.
• Additional Responsibilities: Isolate target proteins from intermediates and process to a sterile bulk and deliver for filling.
• Level II: Performs all duties described at the Purification Operator level. Performs all routine operations associated with actual bulk preparation.

Purification Technician I/II

Research Scientist

• Independently design and manage experiments for testing next-generation antibody therapeutics, including construct design, expression and purification strategies, and implementation of novel analytical assays.
• Provide technical leadership for complex projects which may include elements of protein engineering, synthetic biology, high-throughput sequencing, and in vitro assays.
• Contribute ideas for new assays and technologies to enable the next-generation of GigaGen products and work with management to obtain support and resources to be successful.
• Stay abreast of cutting-edge tools and new technologies related to GigaGen’s antibody discovery platform and coordinate for testing and implementation.
• Contribute to brainstorming sessions and troubleshooting efforts within the team.
• Propose and manage goals, timelines, and personnel for multiple projects, and drive internal and external communications within and across teams to ensure goals are met on time.
• Synthesize and interpret complex data for internal and external presentations.
• Mentor junior lab staff, with opportunities for management of one or more staff.
• Initiate and manage projects with external vendors.

Principal Scientist, Antibody Engineering

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
• Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed

Quality Systems Associate

Bilingual

EMT or Paramedic, Bilingual – Plasma Donation Center

• Perform paced inspections of final container products for multiple categories of defects.
• Document job tasks as required on the Batch Production Record (BPR), Standard Operating Procedure (SOP) document or other acceptable form(s).
• Perform housekeeping tasks and maintain department housekeeping at an optimal level.
• Adhere to all company safety and cGMP policies and practices.
• Set-up, operate and troubleshoot various packaging equipment; Manually package products.
• Inspect packaged and pre-packaged products for possible defects.
• Conduct an accurate count of pre and post packaged products.
• May off load and load products from cages, carts, and boxes; may operate material handling equipment such as pallet jacks, forklifts, etc.

Packaging Technician I/II

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

• Responsible for processing potential blood donors through registration and screening tests
• Performs tasks related to blood collection and centrifuge processes
• Packs and ships blood products and samples

Whole Blood Processor

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.

Grifols

Center Medical Specialist – EMT, Paramedic, LPN/LVN

Donor Center Technician

Phlebotomist

Phlebotomist

Quality Associate II/III, QA, Final Container Release

Purification Technician I/II

Principal Scientist, Antibody Engineering

Quality Systems Associate

EMT or Paramedic, Bilingual – Plasma Donation Center

Packaging Technician I/II

Plasma Processor

Whole Blood Processor

Operations Supervisor

Phlebotomist 2

Phlebotomist