Grifols

Technician

• Responsible for equipment cleaning, setup and operation in a biologics processing environment for plasma derived pharmaceuticals
• Strict adherence to procedures and practices according to FDA regulations
• Strong emphasis on documentation according to FDA regulations
• Adhere to departmental corporate safety policies
• Responsible for facility and equipment cleaning
• All work is performed in a clean room (sanitized) manufacturing environment
• Responsible for performing the following daily tasks: cleaning/ sanitizing aseptic and non-aseptic processing areas, preparing and sterilizing filling and freeze-drying components (such as vials, stoppers, and filling assemblies), and performing aseptic fills
• May be trained in the freeze drying (Lyophilization) process
• Utilizes touch screen Operator Interface Terminals (OIT)

Manufacturing Technician – IGIV Bulk

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.
• 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.

• 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

Operations

• Serves as acting leader in the absence of the Center Manager as assigned
• Maintains the ability to perform any/all tasks within the plasma center; fulfill the role of production employees and supervisor donor flow
• Oversees donor operations and supervise Operation Supervisor(s) and donor center staff during assigned shifts
• This includes provide shift leadership, including staffing coordination, task assignments, break schedules, and coaching of team members
• Creates employee schedules to accommodate donor cycles
• Determines the adequacy and adjust inventory levels of all goods and supplies necessary of the operation of the donor center
• Compile and submit orders to vendors to meet determined inventory levels
• Keeps Center Manager informed of any irregularities within the center and provide action plans to improve and correct center deficiencies
• Supports and executes daily operational plans to achieve center performance targets related to donor throughput, quality, and productivity
• Partners with Center Manager and Quality team to identify and resolve deviations or operational concerns in real time
• Monitors donor flow and proactively address delays or service issues to ensure an exceptional donor experience
• Supervises 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
• Attends 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 assure facility is maintained in a neat and clean condition and all equipment is kept in good working order
• Submits timely and accurate reports as required by the Center Manager
• Assists in the control of center donor funds as determined by the Center Manager
• Participates in the onboarding, training, and cross-training of staff to support center agility and performance.
• Maintains active communication with other service areas to ensure accurate documentation and quality
• Leads by example in promoting a culture of safety, teamwork, and accountability
• Reports all unsafe situations or conditions to area lead, supervisor or manager
• May be trained to repair plasma center equipment
• Assists the Center Manager in any task necessary in pursuit of company objectives.

Operations Supervisor

Manager

• Evaluates processes, develops action plans, and coordinates the strategic implementation of system processes and corrective actions at the plasma donor center
• Maintains oversight of the center’s quality management system and ensures continuous quality improvement, by addressing deficiencies in a timely manner and communicating concerns to the appropriate parties
• Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations
• Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance
• Collaborates with Center Manager to ensure the donor center operates in a manner which assures product quality, donor suitability and donor safety are maintained
• Responsible for the personnel functions of the Quality Systems Associate; including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of personnel records, work schedule and delegation/follow-up of tasks
• Responsible for oversight of all aspects of internal and external audits including audit preparation, execution, response, implementation of corrective/preventative actions, assessment of corrective actions, and follow-up as required
• Continuously assesses, promotes, and improves the effectiveness of the quality and training systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, and direct observations
• Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product
• Investigates identified trends and performs follow-up on corrective and preventive actions, system implementations, and process improvement plans to measure/determine effectiveness
• Oversees product and biohazard waste shipments: Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation; and, authorizes final shipment
• Performs a review of the documentation of unsuitable test results and unit lookback information
• Performs a review of donor adverse event reports and the applicable related documents
• Ensures that job and center annual training (i.e. Advanced cGMP, Blood Borne Pathogen, and others as may be required) is completed, documented, and on file
• Performs employee training observations to ensure staff competency prior to releasing employees to work independently
• Ensures that all supplies and materials ordered meet quality requirements prior to use and are always stored in appropriate temperature/facility conditions
• Initiates appropriate investigations if these requirements are not met
• Initiates rejection of supplies for non-compliance
• Determines donor suitability activities and manages donor deferrals as appropriate
• Reviews and approves deferred donor reinstatement activities
• Prepares quality analysis reports to track issues and set goals
• Does in depth research and analysis to resolve systemic compliance issues
• Ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented
• Holds monthly Quality Meeting to communicate status updates and manage action outcomes
• Leads projects and initiatives as requested

Quality Systems Manager

Director

• Implement the international patient relations strategy in Canada.
• Develop and maintain long-term, trusted relationships with patient organizations and key stakeholders.
• Position Grifols as a credible, responsible, and patient-centered partner.
• Identify and implement strategic collaborations, educational initiatives, and patient engagement programs.
• Represent the patient voice internally and coordinate patient-facing activities.

Corporate Affairs Director

QA Engineer

• Consults with management to develop and implement solutions for achieving quality related objectives
• Assists in the effective deployment of divisional or departmental technical resources in pursuit of annual goals
• Uses expertise to make independent decisions within defined areas of responsibility
• Participates on multi-disciplined project teams
• Advances technical project proposals to senior management
• Collects and analyzes data
• Prepares and reviews SOP revisions, technical reports in DCM, and Change Control Requests
• Demonstrates ability to make sound quality decisions with moderate guidance
• Follows cGMP and department safety practices

Senior Quality Associate I, QA, Final Container Release

Associate

• 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

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.

Manufacturing Technician – IGIV Bulk

Phlebotomist

Donor Center Technician

Donor Center Technician

Donor Center Technician

Donor Center Technician

Donor Center Technician

Operations Supervisor

Quality Systems Manager

Corporate Affairs Director

Senior Quality Associate I, QA, Final Container Release

Quality Systems Associate

Donor Center Technician

Donor Center Technician

Plasma Processor