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 of 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 quality area.Typically requires 2 years of related experience in a medical and/or cGMP regulated environment. Experience with plasma or whole blood.
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*, miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on
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 neck. Light to moderate lifting and carrying objects with a
maximum lift of 35lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; 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.
Ability to apply abstract principles to solve complex conceptual issues.
Grifols - 15 months ago
Grifols doesn't grimace when it comes to working with blood. The company provides products and services through three primary...