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QA Manager
Location:
Hummelstown, PA
Description:
Reaction Biology is a contract research organization (CRO) that was founded in 2001. We provide contract research services to over 1500 clients worldwide through our labs in Malvern and Hershey in Pennsylvania and Freiburg and Heidelberg in Germany. Our clients are seeking answers in their request to discover effective treatments for patients. 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 eQMS system. Working knowledge of KPI's, GLP/ISO requirements, Six Sigma and Lean Manufacturing.
Company:
Reaction Biology
Posted:
December 26 2023 on ApplicantPro
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More About this Listing: QA Manager
QA Manager is a Quality Assurance QA Manager Job at Reaction Biology located in Hummelstown PA. Find other listings like QA Manager by searching Oodle for Quality Assurance QA Manager Jobs.
QA Manager is a Quality Assurance QA Manager Job at Reaction Biology located in Hummelstown PA. Find other listings like QA Manager by searching Oodle for Quality Assurance QA Manager Jobs.