Quality Control Systems Manager - Management
Would you like to join an international team working to improve the future of healthcare? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
We’re Grifols, an international plasma manufacturer headquartered in Barcelona, Spain. We serve healthcare professionals and patients in over 100 countries, have an unmatched record of product quality and safety, and are the largest plasmapheresis company in the world.
If you enjoy working in an environment built around teamwork and trust, then consider furthering your career with us as a QUALITY SYSTEMS MANAGER ! Job Title: QUALITY SYSTEMS MANAGER
Evaluates processes, develops action plans, and coordinates the strategic implementation of system processes and corrective actions.
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.
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.
Also includes 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 Systems 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.
Ensures shipments meet regulatory specifications and product release requirements; 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.
Documents and tracks/trends center quality incidents and follows-up on incidents/errors as required; Ensures that all supplies and materials ordered meet quality requirements prior to use and are stored in appropriate temperature/facility conditions at all times. Directs the maintenance and calibration of equipment and documentation of procedures.
Ensures that Clinical Laboratory 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.
Tracks/Trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness. Ensures that quality control (QC) checks are performed as required and are in acceptable ranges for test reagents.
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.
Performs a review of medical incident reports and the applicable related documentation.
~ Leads projects and initiatives for the region and division.
This job description is intended to present the general content and requirements for the performance of this job. 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 is required.
Typically requires 2-5 years of related WORK experience in a medical and/or cGMP regulated environment.
~ Depending on the area of assignment, directly related work 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 requires a bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of work experience, an associate degree with 6 years of work experience, or a master’s degree with 2 years of work experience.
Strong integrity and commitment to quality and compliance. High level of proficiency with computers. Proficient in root cause analysis and corrective/preventative actions. Strong time management abilities. Proven ability to maintain a high level of quality and compliance and to become a valuable member of the center leadership team. Ability to work with minimal supervision. Ability to travel when needed for meetings, events, and occasional support of other centers.
Work is performed in an office and/or a laboratory/manufacturing environment. 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 drives to site locations with occasional travel within the United States. We offer a comprehensive package of benefits including medical, Paid Time Off (PTO), pharmacy, dental, vision, insurance, life & AD+D insurance, 5% 401K match, and tuition reimbursement. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. app
“We are looking to grow our teams with people who share our energy and enthusiasm for creating the best experience for our donors/customers.”
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Grifols provides equal employment opportunities to applicants and employees without regard to , , , , , , , protected veteran status, or any other characteristic or status protected by law. We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
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