Biomat USA, Inc. Manager in Training (Quality) in Lufkin, Texas
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.
Plasma Center Leadership Trainee (Quality)
* Must be willing to relocate after completion of training *
While in the Center Leadership Development Program (CLDP) the trainee will report to the Leadership Training Manager. Technical training will be planned and directed by a CLDP Designated Trainer at the training center. During the program you will be responsible for learning about and experiencing the daily management of Donor Center Operations and Quality functions; learning to comply with all applicable policies and regulations, as well as comply with Grifols leadership expectations.
Primary responsibilities for role:
● Maintain center compliance with quality standards and regulations. Work with Operations to ensure the collection of a high level of compliant product quality and to maintain a level of donor suitability and safety.
● Learn to manage and monitor processes while ensuring center compliance with all applicable state, federal, and company designated regulations.
● Become responsible for ensuring that Standard Operating Procedures (SOPs) are properly interpreted, implemented in a timely fashion, and that staff performs accordingly to all SOPs.
● Learn how to interpret and implement processes, regulations, and SOPs for quality control and overall regulatory compliance; making independent decisions and modifications as required.
● Become responsible for oversight and of all aspects of internal and external audits including execution (if applicable). This includes documentation, review, and preparation of the response. Continuously assess, promote, and improve the effectiveness of the quality systems in the donor center through recognition of trends, investigations of failures in the execution of procedures, direct employee observations, and review of center documents.
● Become responsible for the personnel functions of the Quality Associate(s); including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of all personnel records, management of work schedule, and delegation/follow-up of tasks.
● Learn product and biohazard waste shipments processes: Ensures shipments meet regulatory specifications and product release requirements, ensures accurate labeling and documentation, and authorizes final shipment.
● Learn how to work in collaboration with the Operations Team to develop the staff’s knowledge of their job function and how their performance relates to the product and patient.
● Learn how to document, investigate, and perform root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and quality of the product.
● Maintain a resume on file at the center.
● Attend and complete the required four weeks of classroom instruction through the Grifols Academy of Plasmapheresis.
● Complete sixteen weeks of hands-on training at the designated training center and complete the manager training modules in the Learning Management System.
Bachelor of Science degree or equivalent.
Certified and proficient in quality and compliance.
Works toward certification from American Society for Quality to be a Certified Quality Auditor.
Works toward certification as a Designated Trainer for the quality area.
Typically requires 2 years of related experience in a medical and/or cGMP regulated environment.
Experience with plasma or whole blood is preferred.
Must be willing to undergo a 5-month leadership course at the Grifols Plasmapheresis Academy.
Must be open to travel out-of-state for training and possible relocation after completion of training.
Knowledge, Skills, and Abilities: Exceptional interpersonal and communications skills including public speaking. Strong time management skills with the ability to manage multiple competing priorities. Must be able to read, write, and speak English. Computer literacy: Word Processing, database software, and spreadsheet programs, proficiency with email and Internet applications.
Work is performed in an office and/or a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to extreme cold below -32 degrees, miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on the production floor. Personal protective equipment required such as protective eyewear, garments, and gloves. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists the neck. Light to moderate lifting and carrying objects with a maximum of 35 lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand it; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.
GRIFOLS IS AN EQUAL OPPORTUNITY EMPLOYER: Minorities / Females / Disability / Veterans
Learn more about Grifols
Req ID: 267888
Type: Regular Full-Time
Job Category: Quality