Location: Hummelstown, PA
Company: Reaction Biology
Finding these answers is our mission as a CRO. Our method is to accelerate the drug discovery process with the widest possible range of assays and services but also to maintain an integrated view of the journey to a lead drug candidate. We strive to provide excellent data, delivered in a timely, collaborative manner by outstanding scientists.
Come join our team! Position Summary: The Quality Assurance Manager is an onsite position out of Hummelstown, PA. They're responsible for ensuring that the company's products meet quality standards and regulations. Also, they're responsible for creating and enforcing the quality standards, procedures, and policies for the company. They work with
the QA team on testing and quality standards, but they also work with employees in general to ensure they understand the quality standards that are required throughout the process.
Quality Assurance Managers stay on top of the latest laws and regulations that impact products. They handle data related to quality to analyze the company's performance as well as quality reports and documentation that are required as part of the QA procedures. Main Responsibilities: Plans, coordinates, and directs quality assurance programs proactively and helps establish standards designed to ensure continuous data quality. Reviews and evaluates inputs related to the Quality Management System for compliance,
trends, effectiveness, and conformance to industry standards as well as applicable international/regulatory requirements.
Review processes and systems on an ongoing basis to determine where improvements can be made; works with operations to revise / establish procedures, standards, and systems. Directly supervise the site Quality Team including the selection and development of people, resources, and budgets necessary to perform the functions of the department; trains workforce as required in various quality methods, standards, and procedures. Conduct announced and unannounced audits for both GLP and non-GLP studies (in vitro and in vivo) to ensure operations are on the highest quality level as well as lead the site internal audit program.
Perform review and data verification of reports for GLP and non-GLP studies, including Study Plans/Protocols, study reports, and ancillary records. Lead SOP management/review cycles along with associated training as well as administer site deviation, CAPA, and change management processes. Ensure training program in place for staff training on procedures introduced by new and revised SOPs, including on-going refresher training as well as OECD Principles of GLP and in compliance with 21CFR58. Monitor care and use of animals to ensure activities are conducted in accordance with the principles outlined in the Guide for the Care and Use of Laboratory Animals, 8th Edition, 2011 (National Research Council) and to ensure compliance with approved IACUC protocols.
Ensure DEA license is kept current via updates and annual renewal and ensure periodic inventory of controlled substances is conducted. Key Qualifications: BS/BSc degree (MS or greater preferred) in relevant scientific field 7+ years of progressive quality assurance background with direct GLP / ISO experience preferred. At least 3+ years prior experience managing and executing internal site audit programs.
Direct experience managing an e QMS system. Working knowledge of KPI's, GLP/ISO requirements, Six Sigma and Lean Manufacturing.
Quality Assurance (QA) jobs involve ensuring that products or services meet certain standards of quality before they reach the consumer. Individuals in QA roles are responsible for planning and implementing inspection processes, conducting tests, and analyzing the results to detect defects. They work to prevent errors and improve the overall quality of the final output. Key characteristics of QA jobs include attention to detail, a systematic approach to problem-solving, and a strong understanding of industry-specific regulations and quality standards. These professionals play a critical role in customer satisfaction and maintaining the reputation of a brand or company.
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.
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.
