Quality Assurance (QA) jobs involve ensuring that products or services meet specific standards and satisfy customer expectations. Professionals in this field focus on systematic processes and preventative measures during production or development to prevent mistakes and defects. QA roles typically require keen attention to detail, problem-solving skills, and knowledge of industry standards. They may encompass various tasks, such as developing quality assurance plans, conducting tests, and analyzing data to improve quality and reliability. QA jobs contribute significantly to a company's reputation by guaranteeing product consistency and safety.
Vice President of Quality. The ideal candidate will be a highly motivated professional who can lead Cartesian's Quality Assurance operations. The role is primarily QA-focused with other broad responsibilities in a fast-paced cell therapy environment. The candidate should embrace a collaborative work environment and be able to execute multiple projects concurrently.
This position is ideal for candidates with experience in GLP/c GMP environments, with knowledge of ICH guidelines and FDA compliance for investigational cell therapy products. Principal Duties/Responsibilities : · MS with 5+ years' experience or Ph D with 2-5 years' experience in biomedical quality control or quality assurance
in positions of increasing responsibility· Supervise the daily operations of the Quality Assurance team. Mentor and train the members of the QA staff. · Manage and improve upon current quality systems for IND enabling functions· Manage lot release with the Director of Quality Control and external partners· Manage quality systems such as document control, change control, deviation, CAPA systems, and management review· Supervise inventory management · Supervise the facility and equipment maintenance · Manage the auditing activities for all suppliers, contract CROs, CMOs, outside testing laboratories, and internal operations· Provide leadership and guidance during regulatory submissions and inspections·
Author, review, and/or approve SOPs/policies and technical reports with general guidance· Lead investigations (Deviations, IA, OOS, AR), performing backssment, authoring protocols/reports and investigation closure with minimal guidance as required· Lead, author, perform, and/or review qualification and validation activities for Manufacturing and Quality Control in collaboration with the Directors of Manufacturing and Quality Control· Author/co-author trending reports and quality reviews to senior management on key performance indicators under Cartesian's QMS Qualifications : · A bachelor's degree or higher in a relevant scientific discipline· At least 10 years of experience in quality assurance in the biomedical industry, with increasing responsibilities and leadership roles (Ideal candidate will have prior experience in cell therapy quality assurance)· In-depth knowledge of current Good Manufacturing Practices (c GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and other applicable regulations and standards· Experience in conducting and hosting internal and external audits and inspections· Experience in developing, implementing, and maintaining quality systems and procedures· Excellent communication, interpersonal, and problem-solving skills· Ability to work independently and as part of a cross-functional team Work Environment: We offer a dynamic, intellectual environment with amenities including: · High tech office setting· Free snacks and beverages· On-site gym· Social, game, and relaxation areas· Electric vehicle charging Depending on expertise this position may require occasional hands-on work (e.
g. to train others) in an R&D laboratory setting. In these instances, employees work in an environment in which safety, environmental, and health concerns require strict adherence to Cartesian's policies, rules and regulations.
This includes use of appropriate safety and personal protective equipment.
Quality Assurance (QA) jobs involve ensuring that products, services, or software meet established standards of quality before they reach the consumer. Professionals in QA roles are responsible for identifying defects, implementing test strategies, and ensuring compliance with industry regulations. Key features of QA jobs include attention to detail, a systematic approach to problem-solving, and a focus on continuous improvement. QA specialists work to prevent errors and enhance customer satisfaction by aiming for zero defects and delivering reliable performance.
Quality Assurance (QA) Jobs encompass roles focused on ensuring that products or services meet established standards of quality, reliability, and performance. These positions typically involve identifying defects, designing test procedures, conducting tests, and making improvements. Key characteristics of QA jobs include attention to detail, a strong understanding of quality metrics, the ability to analyze data, and problem-solving skills. Individuals in QA roles work closely with development teams and are critical in maintaining customer satisfaction by preventing errors and enhancing the user experience.
Quality Assurance (QA) jobs involve the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. The primary goal is to identify defects and issues before the product reaches the customer, thereby ensuring customer satisfaction and maintaining the reputation of an organization. QA roles often require attention to detail, strong problem-solving skills, and a good understanding of industry-specific regulations and standards. These jobs can vary widely, from software testing to food safety inspection, but they universally function as a critical checkpoint in the production and delivery process of goods or services.
Quality Assurance (QA) Jobs encompass roles focused on ensuring that products or services meet established standards of quality, reliability, and performance. These positions typically involve identifying defects, designing test procedures, conducting tests, and making improvements. Key characteristics of QA jobs include attention to detail, a strong understanding of quality metrics, the ability to analyze data, and problem-solving skills. Individuals in QA roles work closely with development teams and are critical in maintaining customer satisfaction by preventing errors and enhancing the user experience.
Quality Assurance (QA) jobs involve ensuring that products, services, or processes meet established standards of quality through systematic activities and measures. These roles typically focus on preventing defects, identifying potential issues, and implementing solutions to maintain quality consistency. Key features of QA positions include rigorous testing, meticulous attention to detail, and a commitment to continuous improvement. QA professionals work across various industries, from software development to manufacturing, to safeguard customer satisfaction and comply with regulatory requirements.
Quality Assurance (QA) Jobs encompass roles focused on ensuring that products or services meet established standards of quality, reliability, and performance. These positions typically involve identifying defects, designing test procedures, conducting tests, and making improvements. Key characteristics of QA jobs include attention to detail, a strong understanding of quality metrics, the ability to analyze data, and problem-solving skills. Individuals in QA roles work closely with development teams and are critical in maintaining customer satisfaction by preventing errors and enhancing the user experience.
Quality Assurance (QA) jobs involve ensuring that products, services, or software meet established standards of quality before they reach the consumer. Professionals in QA roles are responsible for identifying defects, implementing test strategies, and ensuring compliance with industry regulations. Key features of QA jobs include attention to detail, a systematic approach to problem-solving, and a focus on continuous improvement. QA specialists work to prevent errors and enhance customer satisfaction by aiming for zero defects and delivering reliable performance.
