Senior Quality Assurance Compliance Auditor Drug Development 9354
3 weeks ago
Essential duties:
- Conduct work as identified on the audit activity list
- Contributes to global QA policies on interpretation/ application of regulations
- Provide subject matter expertise to projects Support team in CAPA plan creation
- Hosts external audits/inspections e.g. regulatory inspections, strategic clients. Assists with the facilitation of audit responses
- Supports the QA–to-QA relationship with key client(s)
- Delivery of training in performance of audits (basic, intermediate, complex)
- Participate (for multi-regulatory topics in area of expertise) global Quality initiative(s) aimed at improving compliance and/or efficiency of the QA organization
- Supports the reporting of quality metrics and implementation of necessary corrective actions and/or process improvements via appropriate forum (e.g. Monthly Reports, Site Quality Review, Liaison meetings)
- Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
- Other duties as assigned by management.
-
Quality Assurance Engineer
3 weeks ago
Indianapolis, Indiana, United States Enovis Full timeJob Description:At EnovisTM we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence — with the goal of transforming medical technology as we know it.Because that's how we change the lives of patients for the better. And that's how we create better together.As a key member of...
-
Quality Assurance Compliance Analyst
1 week ago
Indianapolis, Indiana, United States Novartis Full timeJob OverviewPosition Summary:This role is a temporary contractor position at Novartis, a company that significantly impacts the health of millions worldwide.About the Role:The Quality Assurance Compliance Analyst is responsible for establishing and maintaining effective Quality Systems in alignment with Novartis and regulatory standards. This position plays...
-
Indianapolis, Indiana, United States Merck KGaA Full timeAbout the RoleThis position supports the quality assurance processes within the QA Supply Chain department with a focus on transforming the way we work through continual improvement, ownership of transformative CAPAs and projects. The Senior Quality Assurance Supply Chain Associate will be responsible for improving site compliance, deploying risk-based...
-
Indianapolis, Indiana, United States Merck KGaA Full timeAbout the RoleThis position supports the quality assurance processes within the QA Supply Chain department with a focus on transforming the way we work through continual improvement, ownership of transformative CAPAs and projects. The Senior Quality Assurance Supply Chain Associate will be responsible for improving site compliance, deploying risk-based...
-
Quality Assurance Manager
22 hours ago
Indianapolis, Indiana, United States FFP Full timeJob DescriptionJob Summary:The Quality Assurance Supervisor is responsible for overseeing the quality assurance activities on the production floor, ensuring that all products meet established quality standards and regulatory requirements. This role involves supervising quality assurance teams, conducting audits, managing documentation, and collaborating with...
-
Coding Compliance Auditor
5 days ago
Indianapolis, Indiana, United States Franciscan Health Full timePosition OverviewAs a vital member of our healthcare team, the Coding Compliance Auditor plays a crucial role in ensuring the accuracy and compliance of coding practices within our organization. With a commitment to excellence, you will contribute to the integrity of our coding processes and support our mission of providing high-quality care.Key...
-
Final Compliance Auditor
1 week ago
Indianapolis, Indiana, United States Vitu Full timeJob OverviewVitu is at the forefront of delivering advanced solutions to the automotive sector. Our flagship platform streamlines the management of titling and registration processes across all 50 states, enhancing the interaction between drivers, businesses, and governmental entities.Position Summary:The Final Compliance Auditor plays a crucial role in...
-
Coding Compliance Auditor
1 week ago
Indianapolis, Indiana, United States Franciscan Health Full timePosition OverviewAs a vital member of the Franciscan Health team, the Coding Compliance Auditor plays a crucial role in ensuring adherence to coding standards and regulations. This position is essential for maintaining the integrity of our coding processes and supporting our mission of providing exceptional healthcare.Key ResponsibilitiesConducts thorough...
-
Coding Compliance Auditor
5 days ago
Indianapolis, Indiana, United States Franciscan Health Full timePosition OverviewAs a Coding Compliance Auditor, you will play a vital role in ensuring adherence to coding standards and reimbursement protocols within our healthcare system. Your expertise will contribute to the overall quality of patient care and operational efficiency.Key ResponsibilitiesConduct thorough evaluations of hospital inpatient coding...
-
GQAAC Quality External Reporting and Compliance
3 weeks 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...
-
Senior Quality Assurance Technician
1 week ago
Indianapolis, Indiana, United States HGC Industries Full timeJob OverviewThe Senior Quality Assurance Technician plays a pivotal role in supporting HGC Industries' mission and core values by executing various responsibilities to ensure the Quality Management System operates effectively. This position involves leading process and documentation modifications as part of the introduction of new products, utilizing...
-
Quality Assurance Supervisor
4 hours ago
Indianapolis, Indiana, United States MBV-CA LLC Full timeJob DescriptionJob Summary:We are seeking a highly skilled and experienced Quality Assurance Supervisor to join our team at MBV-CA LLC. The successful candidate will be responsible for overseeing the quality assurance functions, ensuring compliance with regulatory requirements, and implementing quality control measures to maintain the highest standards of...
-
Quality Assurance Specialist
2 days ago
Indianapolis, Indiana, United States Net2Source Inc. Full timeJob Title: Quality Assurance SpecialistLocation: LafayetteDuration: 24 Months ContractShift: First ShiftPay rate: $45-$51 an hour on W2Summary:The main function of a Quality Assurance Specialist is to research and test the design, functionality, and maintenance of products, equipment, systems, and processes to develop quality standards. A typical Quality...
-
Quality Assurance Supervisor
2 weeks ago
Indianapolis, Indiana, United States Careerbuilder-US Full timeJob Title: Quality Assurance Supervisor Job Location: Indianapolis, IN Job Duration: Full Time + Benefits Shift: 7:00 am - 3:30 pm Job Overview: The Quality Assurance Supervisor plays a pivotal role in guiding the QA team. This position involves addressing disputes among team members and fostering collaboration across different groups. Key...
-
Quality Assurance Team Leader
5 days ago
Indianapolis, Indiana, United States FFP Full timeJob OverviewPosition Summary:The Quality Assurance Team Leader is tasked with overseeing the quality assurance operations on the production floor, ensuring that all products adhere to established quality benchmarks and regulatory standards. This position involves managing QA Floor Technicians, performing audits, handling documentation, and collaborating with...
-
Lead Quality Assurance Strategist
5 days ago
Indianapolis, Indiana, United States RBW Consulting Full timeSenior Quality Assurance ManagerCDMO - Sterile InjectablesOn-site OpportunityOur esteemed CDMO partner, recognized for its excellence in sterile manufacturing, is embarking on an exciting expansion following the acquisition of two facilities from a major global pharmaceutical entity. This growth presents a unique opportunity for a skilled professional to...
-
Regulatory Compliance Officer
2 days ago
Indianapolis, Indiana, United States Genezen Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Genezen. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products and processes.Key ResponsibilitiesProvide quality oversight and expertise to operations, manufacturing, and quality control...
-
Quality Assurance Specialist
2 hours ago
Indianapolis, Indiana, United States FFP Full timeJob OverviewAs a Quality Assurance Technician at FFP, you will play a critical role in ensuring the safety and quality of our products. Your attention to detail and analytical skills will contribute to the overall success of our quality program.Key Responsibilities:Perform inspections and tests on raw materials, work-in-progress, and finished...
-
Quality Assurance Specialist
1 week ago
Indianapolis, Indiana, United States FFP Full timeJob OverviewThe Quality Assurance Specialist plays a vital role in ensuring Food Safety and Quality standards are met. This position involves verifying documentation, guiding team members in adhering to best practices, and assisting in root cause analysis. The specialist collaborates with various teams to conduct daily analytical, sensory, and...
-
Quality Assurance Specialist
1 week ago
Indianapolis, Indiana, United States MBV-CA LLC Full timePosition OverviewThe Quality Assurance Technician plays a critical role in maintaining the integrity of beverage production by conducting thorough quality assurance audits. This position ensures that both company and customer standards are upheld while adhering to all relevant regulations.Key Responsibilities:Conduct regular audits of beverage production to...