Quality Systems Manager
2 months ago
table.MiTabla { max-width: 1020px;important
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? 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.
Quality Systems & Training Manager
Summary:
Evaluates processes, develops action plans, and coordinates the strategic implementation of quality system processes and corrective actions at the plasma donor center. Include who they report to and what positions have on the team.
Education:
Bachelor of Science degree or equivalent.
Primary Responsibilities for role:
● Maintains oversight of the center’s quality management system and ensures continuous quality improvement, by addressing deficiencies in a timely manner and communicating concerns to the appropriate parties.
● Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations. Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance.
● Maintains oversight of center training program by ensuring compliance to program requirements promoting staff competency in their assigned job duties. Maintains and audits training records and files.
● Collaborates with Center Manager to ensure the donor center operates in a manner which assures product quality, donor suitability and donor safety are maintained.
● Responsible for the personnel functions of the Quality Associate; including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of personnel records, work schedule and delegation/follow-up of tasks.
● Responsible for oversight of all aspects of internal and external audits including audit preparation, execution, response, implementation of corrective/preventative actions, assessment of corrective actions, and follow-up as required.
● Continuously assesses, promotes, and improves the effectiveness of quality and training systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, and direct observations.
● 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.
● Investigates identified trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness.
● 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 unit lookback information.
● Performs a review of donor adverse event reports and the applicable related documentation.
● Ensures that job and center annual training (i.e. Advanced cGMP, Blood Borne Pathogen, and others as required) is completed, documented, and on file.
● Performs employee training observations to ensure staff competency prior to releasing employees to work independently.
● Ensures that all supplies and materials ordered meet quality requirements prior to use and are always stored in appropriate temperature/facility conditions. Initiates appropriate investigations if these requirements are not met. Initiates rejection of supplies for non-conformance.
● Determines donor suitability activities and manages donor deferrals as appropriate. Reviews and approves of deferred donor reinstatement activities.
● Prepares quality analysis reports to track issues and set goals. Does in depth research and analysis to resolve systemic compliance issues
● Ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented.
● Holds monthly Quality Meeting to communicate status updates and manage action outcomes.
#BiomatUSA
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws
Location: NORTH AMERICA : USA : IN-Indianapolis:USNC0801 - Peoria IL-N Sheridan Rd-TPR
Learn more about Grifols
-
Quality Systems Manager
2 months ago
IN-Indianapolis, United States GRIFOLS, S.A. Full timetable.MiTabla { max-width: 1020px;!important Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? 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...
-
Manager of Quality Systems
3 weeks ago
Indianapolis, United States Surf Search Full timeOur quality standards are recognized within the global community. We are seeking a quality professional to continue our pursuit of quality excellence in the role of Manager of Quality Systems. In this role will manage the design and maintenance of the Quality and Engineering systems to comply with best practices and hygienic standards.The Manager of Quality...
-
Quality Systems Manager
2 months ago
Indianapolis, Indiana, United States GRIFOLS, S.A. Full timeWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? 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...
-
Quality Management Systems Specialist
2 months ago
Indianapolis, United States Merck Group Full timeThe Quality Management System (QMS) Specialist role involves overseeing the Quality Assurance (QA) program and quality systems at the site level. This includes maintaining oversight of the QA program from a QMS perspective, running weekly CAPA Review Board (CRB) and Quality Review Board (QRB) meetings, developing high-level dashboards, preparing periodic...
-
System Engineer
3 months ago
Indianapolis, United States Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Senior Director-Global Quality Systems-Quality
2 months ago
Indianapolis, United States Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Senior Director-Global Quality Systems-Quality
2 months ago
Indianapolis, Indiana, United States Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Quality Manager
4 weeks ago
Indianapolis, United States Affinity Executive Search Full timeJob description: Our quality standards are recognized within the global community. We are seeking a quality professional to continue our pursuit of quality excellence in the role of Quality Supply Chain Manager. In this role will manage the design and maintenance of the Quality and Engineering systems to comply with best practices and hygienic standards.The...
-
Quality Systems Associate
1 month ago
IN-Griffith, United States GRIFOLS, S.A. Full timeWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? 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...
-
Quality Systems Associate
1 week ago
IN-Griffith, United States GRIFOLS, S.A. Full timetable.MiTabla { max-width: 1020px;!important Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? 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...
-
Quality Systems Associate
3 months ago
IN-Griffith, United States GRIFOLS, S.A. Full timetable.MiTabla { max-width: 1020px;!important Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? 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...
-
SAP Project Systems Manager
3 months ago
Indianapolis, IN, United States Deloitte Full timePosition Summary Industry-leading clients. An award-winning culture. Top notch connections. Big opportunities. From learning to leadership, this is your chance to take your career to the next level. Deloitte can show you what it takes to explore an entire universe of ideas, possibilities, and opportunities—and help make an impact that matters with...
-
Quality Assurance Tester
1 month ago
Indianapolis, United States Apex Systems Full timeJob Title: QA TesterLocation: Indianapolis, INContract Duration: Long term contract to *potential* hirePay: $28/hourSend your resume to bvallen@apexsystems.com to apply directly! NO C2CThe main function of a QA Tester at this level is to apply test skills at a basic level. The QA Tester will perform repeatable testing procedures and may need to be familiar...
-
Quality Assurance Tester
1 month ago
Indianapolis, United States Apex Systems Full timeJob Title: QA TesterLocation: Indianapolis, INContract Duration: Long term contract to *potential* hirePay: $28/hourSend your resume to bvallen@apexsystems.com to apply directly! NO C2CThe main function of a QA Tester at this level is to apply test skills at a basic level. The QA Tester will perform repeatable testing procedures and may need to be familiar...
-
Quality Assurance Manager
4 weeks ago
Indianapolis, United States Futures Consulting LLC Full timeQUALITY ASSURANCE MANAGER Indianapolis, INSalary Range: $90-100,000 Shift | Hours: 1st shift | Monday – Friday (Saturday as needed)The Quality Assurance Manager is responsible for ensuring that all products produced in the food manufacturing facility meet the highest standards of quality, safety, and compliance with...
-
Site Leader
4 days ago
Indianapolis, Indiana, United States TRIGO Global Quality Solutions Full timeJob DescriptionTRIGO Global Quality Solutions is seeking a highly skilled and experienced Traveling Site Leader to join our team.Job Summary:The Traveling Site Leader will be responsible for ensuring quality services and support for all missions assigned to their site(s). This includes providing leadership and guidance to personnel fulfilling missions,...
-
Principal Systems Safety Engineer
1 month ago
Indianapolis, United States Associates Systems LLC Full timeMust be a U.S. Citizen with the ability to obtain and maintain a DoD Secret Security Clearance As a member of the Engineering Team, expect a dynamic and demanding environment that values discipline, adherence to processes, and adding value to our customers through our respective disciplines. This position serves as a member of the Engineering Team and...
-
Indianapolis, Indiana, United States InPwr Full timeJob OverviewInPwr, Inc. is seeking an experienced QA/QC Data Center Commissioning Agent to enhance our innovative team. As a recognized leader in electrical design and construction, we pride ourselves on delivering exceptional service and quality across various projects nationwide.Compensation and Benefits:Comprehensive Medical, Dental, Vision, and Life...
-
Plant Quality Manager
2 weeks ago
Indianapolis, United States Aegis Worldwide Full timeAegis WorldwideQuality ManagerDirect Hire, M-F 7a-4pIndianapolis/GreenwoodAegis Worldwide is partnering with a manufacturing client on the southside of Indianapolis who is looking to add a Quality Manager to their team! My client is looking to add an above and beyond Quality Manager who is excited to help shape culture and processes. The ideal candidate will...
-
Plant Quality Manager
2 weeks ago
Indianapolis, United States Aegis Worldwide Full timeAegis WorldwideQuality ManagerDirect Hire, M-F 7a-4pIndianapolis/GreenwoodAegis Worldwide is partnering with a manufacturing client on the southside of Indianapolis who is looking to add a Quality Manager to their team! My client is looking to add an above and beyond Quality Manager who is excited to help shape culture and processes. The ideal candidate will...