Grifols Shared Services North America, Inc Center Leadership Trainee - Quality in raleigh, North Carolina
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
Headquartered in Barcelona, Spain, Grifols has over 20.000 employees in 30 countries. Grifols’ three main divisions - Bioscience, Diagnostic and Hospital - develop, manufacture and market innovative products and services available in more than 100 countries.
With the world's largest network of plasma donation centers, Grifols, through its Bioscience Division, is a leading producer of essential plasma-derived medicines for the treatment of rare, chronic, and sometimes life-threatening conditions. To help ensure a reliable and consistent source of plasmaderived medicines worldwide, we have an integrated production process that begins with plasma collection and continues through fractionation and purification at our three facilities located in Spain (Barcelona) and the United States (Clayton, North Carolina, and Los Angeles, California). Key products include immunoglobulins, alpha-1 antitrypsin, albumin, clotting factors and specialty products.
* Must be open to relocating after completion of training *
We’re Grifols, an international plasma manufacturer headquartered in Barcelona, Spain. We serve healthcare professionals and patients in over 90 countries, have an unmatched record of product safety, and are the largest plasmapheresis company in the world. We offer full healthcare benefits, tuition reimbursement, and some of our Academy courses even count for college credit!
If you enjoy working in an environment built around teamwork and trust, then consider furthering your career with us as a CENTER QUALITY MANAGER, Please read on ...
Primary responsibilities for role:
Independent level of quality inspection and control -- ensures center compliance with quality standards and regulations. Collaborates with Center Managers to ensure product quality, donor suitability and donor safety.
Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations.
Ensures that Standard Operating Procedures (SOPs) are properly interpreted, implemented in a timely fashion, and that the staff performs according to all SOPs.
Interprets and implements processes, regulations, and SOPs for quality control and overall regulatory compliance, making independent decisions and modifications as required.
Oversight of all aspects of internal and external audits including execution (if applicable). This includes documentation, review and preparation of the response. Continuously assesses, promotes, and improves the effectiveness of the quality systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, direct employee observation and review of center documents.
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.
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 the disposition of the associated results.
Works in collaboration with the Center Manager to develop the staff’s knowledge of their job function and how their performance relates to the end product and patient.
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.
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.
Must be willing to undergo a 6-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.
NOTE: Ability to relocate is highly-preferred!
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 35Ibs. 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.
Learn more about Grifols
Req ID: 134487
Type: Regular Full-Time
Job Category: Quality