Grifols

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
• Attend all required training sessions, staff meetings, etc.
• Ensure accurate and thorough documentation of necessary records is performed
• 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 training of new employees and retraining of current employees

Operations Supervisor

• Overseeing daily activities of donor floor operations
• Supervising staff
• Supporting compliance with regulatory and quality standards
• Acting leader in the absence of the Center Manager
• Staffing coordination, task assignments, break schedules, and coaching of team members
• Ensuring execution of operational priorities
• Monitoring donor flow and proactively addressing delays or service issues

Senior Operations Supervisor

Risk

• Executes evaluations of quality systems
• Champions data integrity and risk management initiatives
• Conducts evaluations of data derived from equipment
• Critically evaluates quality metrics and emerging trends
• Authors comprehensive Deviation Reports, CAPAs, and Effectiveness Checks

Quality Risk Specialist

Systems Engineer

• Champions the customer voice by collaborating with Systems Product Owners to capture, interpret, and integrate feedback into product planning
• Delivers actionable, data-driven insights to Marketing, Support, and Technology teams by analyzing product performance metrics
• Serves as a third-level escalation point for complex product issues
• Leads risk management activities in accordance with FDA and ISO regulations
• Leads in-depth technical investigations in collaboration with engineering, QA, and operations teams
• Monitors and analyzes customer feedback from support tickets, surveys, forums, and direct interactions
• Participates in Product Health Safety Committee (PHSC) activities
• Designs and executes system performance validation studies
• Develops and executes comprehensive testing protocols
• Contributes to the creation, review, and validation of technical documentation
• Collaborates with development partners, project managers, and cross-functional teams
• Mentors colleagues within the Product Development and Support (PDS) team
• Supports verification and validation (V&V) activities

Senior Systems Engineer – Customer Complaints Management

Research Analyst

• Assists in the management of the clinical monitoring process
• Ensures coordination of study start-up
• Tracking study specific tasks and progress of the trial
• Performing regulatory document review and approval
• Conducting monitor training

Clinical Research Associate – 2

Manager

• Responsible for the review of all investigations for deviations, environmental monitoring excursions and calibration investigations related to Manufacturing, Maintenance and Packaging and assessing the impact on product and/ or production.
• Oversees the completion of investigation reports, including identification of product impact root causes and determination of corrective actions.
• Work closely with the Manufacturing, Quality Assurance, Maintenance/ Facilities, and other departments to ensure prompt closure of deviation reports.
• Identify areas where deviation/corrective maintenance reoccurrence could be avoided.
• Review manufacturing, facilities, environmental monitoring documentation and other documentation, as required, to ensure it supports the investigation reports generated by the team.
• Manage and monitor department's operating budget.
• Assume the decision-making responsibility for day-to-day operations considering staff input and collaborating with other GBI functions.
• Provide scientific and/or technical advice and counsel regarding projects as needed.
• Communicates company and departmental goals to the department's exempt and non-exempt employees.
• Communicates with cross functional departments and support groups to improve departmental performance and efficiency.
• Maintain current knowledge of regulatory and industry standards.
• Review investigations, reports generated for out-of-specification results or out-of-procedure events.
• Participate in regulatory and internal inspections/audits including providing written responses for area of responsibility, if necessary.
• Provide guidance and hands-on training to direct reports.
• Appraise and monitor performance of department personnel.
• Coach, counsel, address complaints and resolve employee related issues with the collaboration of Human Resources, as necessary.
• Provide a leadership role ensuring employee health and safety.
• Involved in interviewing/selection process of hiring or promoting department personnel.

Manager, Manufacturing Assurance

Bilingual

• 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

Basic or Advanced EMT, Bilingual in Spanish Preferred

Compliance

• Accurately prepare regulatory applications required by federal and other regulatory authorities.
• Research internal documents, complete applications, and forms; prepare cover letters and summaries.
• Submit and monitor application submission for timely review and acceptance.
• Provide updates to management on the status of applications.
• Maintain applicable shared mailboxes, dashboards and accounts related to administrative licensing activities.

Plasma Regulatory Affairs Associate

Sales

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Sales Specialist, Prolastin

• Accurately prepare regulatory applications required by federal and other regulatory authorities
• Submit and monitor application submission for timely review and acceptance
• Maintain applicable shared mailboxes, dashboards and accounts related to administrative licensing activities
• Educate and inform internal customers regarding regulatory requirements as it pertains to licensing activities

Plasma Regulatory Affairs Associate 1

EMT or Paramedic, Bilingual Preferred

Analyst

• Serve as the on-site IT point of contact for QC laboratories and Quality teams
• Provide functional and technical support for LabVantage LES
• Implement and maintain lab execution configurations in LabVantage LES
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