Grifols Shared Services North America, Inc Plasma Center Quality Assurance Manager - San Diego, CA in San Diego, California
Grifols is a global healthcare company whose mission is to improve the health and well being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
Excellent Opportunity for the Right Center Quality Assurance Manager! As a Center Quality Manager you will ensure that our plasma center is "inspection ready" at all times by managing adherence to Standard Operating Procedures (SOPs), and must be comfortable hosting audits, as well as leading and developing a team of Quality Associates. If you a leader looking for the next step in your career and want to join a company making a difference in patients' lives, apply now!
Our center is located at: 7150 El Cajon Blvd. San Diego, CA 92115
Center Quality Manager
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 of and preparation of the response.
Also including implementation of corrective and preventative action, assessment of corrective and preventative actions and follow-up as required.
● 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 Assoc(s); including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of all
● 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.
● 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.
● Documents and tracks/trends center quality incidents and follows-up on incidents/errors as required; reports critical incidents and problematic trends to Center Manager.
● Reports compliance status to necessary parties.
● Ensures accuracy of donor files.
● Directs the maintenance and calibration of equipment and documentation of procedures.
● Ensures that Clinical Lab Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented.
● Monitors training documents to ensure compliance with all applicable policies and procedures.
● Ensures that job and Current Good Manufacturing Practice (cGMP) training is completed, documented, and on file.
● Ensures that quality control (QC) checks are performed as required and are in acceptable ranges for test reagents.
● QM directs routine verification of the SOP and forms to ensure that they are up to date in the Donor Center’s manual.
● Partners with the Center Manager to determine donor suitability activities and manages donor deferrals as appropriate.
● Prepares quality analysis reports to track issues and set goals. Does in depth research and analysis to resolve systemic compliance issues.
● Builds rapport with donors to ensure overall customer satisfaction with the Center to support long-term donation.
Education: Bachelor of Science degree or equivalent.
Equivalency: Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level typically requires an Associate’s degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor’s degree.
Certified and proficient in quality and compliance.
Works toward certification from the American Society for Quality to be a Certified Quality Auditor.
Works toward certification as a Designated Trainer for the quality area.
Occupational Demands: 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.
Learn more about Grifols at http://www.grifols.com/es/web/international/home