Biomat USA, Inc. Manager, Laboratory (RPSTO) in Boca Raton, Florida
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
Manager, Laboratory (RPSTO)
This position is responsible for the administration of the assigned, laboratory functions of the Plasma collection programs and for coordination and planning of program strategies with Plasma Operations. Management of the RBC processing and inventory. Management of laboratory projects. Overseeing training and documentation of training for laboratory personnel. Management and direction of laboratory personnel. Developing, planning and coordinating laboratory strategies for efficiency in throughput, minimal reagent loss and high-quality testing and results while meeting all federal, state regulations and contract requirements.
ESSENTIAL JOB FUNCTIONS:
Manages all operations and procedures in RBC Processing and Specialty Testing Operations (Immunohematology, Immunoassay, RBC manufacturing).
Manages the Anti-D program functions associated with the laboratory by performing the following: individual anti-D donor screening and testing, all paperwork involving selection, certification and monitoring of whole blood donors (RBCs), manage RBC inventory, coordinates strategies with Specialty Plasma Program Management.
Determines, in conjunction with the Plasma Medical Affairs Director or designee and Specialty Plasma Program Management, the suitability of whole blood (RBC) donors.
Schedules production orders of RBCs for immunization. Coordinates shipment of RBC vials with Specialty Plasma Program Management.
Coordinates laboratory mini-pool (anti-D, anti-HBs, anti-Tetanus, etc.) preparation functions and testing with Specialty Plasma Program Management (Customer Operations).
Conducts all investigations associated with adverse events related to RBC immunizations and/or sterility failures. Coordinates with Specialty Plasma Program Management and helps assess Center in investigations. Provides the necessary information to the Plasma Medical Affairs Director or designee and to Specialty Plasma Program Management. Participates on the Sterility Failure Investigation Committee.
Establish and monitor new employee training and verify appropriate new employee documentation is complete and properly filed. Assures proficiency for employees is up to date, monitors needs and schedules the necessary training.
Assure that the Director is updated as to the status of production, projects, any problem areas, personnel difficulties, exceptional performance, and any operational information, as required.
Ensure that the assigned laboratories meet all regulatory requirements by verifying procedures are being followed, all required recordkeeping is current, proper equipment/reagent maintenance occurs and new requirements are identified as they arise.
Directs staff, as necessary, in discretionary decisions regarding problem test runs by analyzing test results and deciding the appropriate course of action.
Evaluate and recommend new test methodologies, as necessary, including cost analysis, work flow, instrumentation and staffing requirements. Coordinate and manage all changes implemented in the laboratory in compliance with Change Control.
Maintain efficient work throughput by analyzing testing volumes, staff allocations, and testing turn-around time and identifying problem areas where corrective action is needed.
Achieve minimal reagent loss by establishing and maintaining accurate systems for inventory control and accountability of all tests performed. Analyze the data generated from these systems to establish appropriate strategies to maximize test run size thus minimizing reagent usage.
Write and review technical procedures to assure testing standardization, quality of work, and adherence to applicable regulations. Review manufacturer’s instructions and analyze essential work steps to understand procedure requirements.
Maintain inspection / audit readiness to assure successful regulatory inspections (FDA, CLIA, etc.) and customer & internal audits.
Evaluate and Investigate all exceptions (Deviations) and Laboratory Feedback Reports, determining root cause and development of corrective and preventative action plans.
Coordinate and review changes made to the computer systems shared with Plasma Operations, Specialty Plasma Program Management (LIMS, BECS, Anti-D Donor Card, etc.).
Hold regular meetings (group and one on one meetings) to monitor staff’s performance; taking the necessary appropriate action in a timely manner.
Assists in other functions and projects as assigned by the Director or management.
Bachelor’s degree in Medical Technology, Biological Science or Laboratory Management. Medical Technology training.
Minimum five years in Chemistry, Immunohematology, Serology or general laboratory field. Must have Florida Department of Professional Regulation (DPR) Supervisor License with minimum five years of hands-on laboratory supervisory experience (or equivalent).
Capacity for independent functioning and decision making; ability to take initiative and carry out projects appropriately with minimal direction; strong communication, supervision, and customer service skills; ability to prioritize and troubleshoot in work flow and human resource areas; ability to exercise logical resourceful thinking and demonstrate flexibility while handling multiple priorities; ability to evaluate urgent situation and take appropriate action while maintaining control in crisis situations; ability to develop and foster teamwork between shifts and other departments. Ability to operate computer and generate programmed reports. Ability to revise procedures and department instructions.
WORK ENVIRONMENT/PHYSICAL DEMANDS/TRAVEL:
Internal – Frequent interaction with various management functions and staff of related departments.
External – Contact with vendors.
Direct Work of Others: Oversees all aspects of employment relationship for laboratory personnel. Hiring, staffing and performance review.
Decision Making: Supervise all testing relating to Specialty Plasma Programs (Anti-D, Anti-Hbs, etc.), donor requirement testing, mini-pool preparation and testing, and RBC production for immunization affecting production of Anti-D plasma. Generate Laboratory Operations Reports and prepare appropriate corrective/preventative action plans.
Challenges: Maintaining effective laboratory operations with an efficient flow of work and highly accurate record-keeping while achieving Biomat’s quality standards within budget restrictions.
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols
Req ID: 337450
Type: Regular Full-Time
Job Category: Others