For over 40 years, Charles River Cell Solutions has worked to making a positive impact on the world by providing the highest quality cellular material and services to biotech and pharmaceutical companies and research organizations that are performing innovative research and developing novel cell-based therapies. We recognize that our success depends on the vision and passion of our employees; that is why we are devoted to making Cell Solutions a rewarding and valuable place to work. We believe in making a difference, and at Cell Solutions, you will make a difference every day. **Job Summary** This position will provide support to ensure the organization maintains compliance with the organization's Quality Systems, current Good Manufacturing Practices (cGMPs), current Good Tissue Practices (cGTPs), and in adherence with all applicable Federal, State, local, international, and industry regulations and standards. This position will also oversee the management of regulatory documentation related to the organization's Institutional Review Board (IRB) activities. Will assist with the new and ongoing qualification of suppliers performing collections. The position works closely with QA management staff, the Medical Director, Operations Team, etc. to ensure all regulatory documents and requirements are met. This individual will perform a variety of activities needed to establish and maintain compliance; including responsibilities associated with the quality assurance tasks. **Essential Responsibilities** * Perform job functions in compliance with internal Standard Operating Procedures, Current Good Manufacturing and Tissues Practices, all Federal and State regulations and accrediting agency standards. * Update site licenses and registrations. * Maintain all forms, logs and other applicable records and spreadsheets related to the job functions. * Review batch records and release products. * Revise/review policies and procedures. * Initiate deviations and perform preliminary review of major/critical deviations. Work closely with all departments to ensure deviations are thorough and closed on-time. * Assist in the preparation of records prior to and during external assessments. * Perform internal and external supplier audits. * Manage the inspection/back room during regulatory or customer audits. * Review validation reports (IQ/OQ/PQ) * Manage or support the Quarterly Management Review meetings. * Assist other QA staff with regulatory and quality functions as deemed necessary. * Manage documentation associated with all IRB activities related to sponsor and study site submissions and approvals for studies where our organization is the sponsor. * Assist QA management with all IRB submission activities, including but not limited to the following: o Annual reporting for approved studies and study sites o Protocol and informed consent revisions o New study site submissions and approvals o Recruitment material submissions and approvals o Adverse event or protocol deviation reports * Work with departmental staff to ensure internal operational procedures and protocols are developed to comply with study protocol requirements. * Complete forms and generates all reports necessary to comply with regulatory requirements and institutional policies. * Manage or assist supplier qualifications of contracted collection entities operating under separate IRB study protocols and consents. * Provide IRB approval documentation to customers, sales, and marketing staff, as needed * Assist with the management of Quality System Reports (QSRs), including deviations, change control, corrective and preventive actions (CAPA), exceptions, customer complaints, and post-donation information. Notify management and departments for any issues impacting SQuIPP of products. **Job Qualifications** * B.S., B.A. or Associate Degree in life sciences is preferred. * Minimum ten (10) years of related experience in QA or equivalent combination of education and experience. * Nationally recognized Research Professional Certification (e.g., ASQ certification in auditing, SOCRA, CRS or Association for Clinical Research Professional) highly preferred. Compensation Data The pay range for this position is $41.81 - $44.24 per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. **About Charles River Cell Solutions** Charles River Cell Solutions is a global leader and trusted brand in the customization of human-derived biological products and services for biomedical research, drug discovery, and cell and gene therapy development. Cell Solution's vertically integrated solutions support preclinical research, clinical studies from phases 1 to 3, and commercialization with high-quality RUO and GMP-compliant starting material and apheresis collections. In January 2020, HemaCare was acquired by Charles River Laboratories, an early-stage contract research organization (CRO). Combined with Charles River's integrated, early-stage portfolio of discovery, safety assessment, and manufacturing support services, the acquisition creates a unique, comprehensive solution for researchers and cell therapy developers and manufacturers worldwide to help accelerate their critical programs from basic research and proof-of-concept to regulatory approval and commercialization. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs and enhances their productivity and effectiveness to increase speed to market. We work closely with our clients throughout the clinical process to maximize success and drive positive clinical outcomes. Together, with over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical and biotechnology companies, government agencies, and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. At Cell Solutions, we are passionate about our role in improving the quality of people's lives. We have proudly supported the development of 100% of the current commercially available FDA-approved immunocellular therapies. Our mission is to provide a best-in-class portfolio of high quality, customizable human cellular material and services to support drug discovery, scientific research, and cell therapy. This resonates from our employees and impacts our customers because we know that every day is an opportunity to advance discoveries and make a difference in someone's life. We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility. **Equal Employment Opportunity** Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit www.criver.com. 226620