Senior Quality Systems Specialist

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about. Job Overview BASIC SUMMARY: Responsible for assisting / performing facility, process, vendor and local validation activities to assure compliance with applicable federal, state, and local regulations as well as corporate policies, Good Manufacturing Practice (GMP), applicable ISO requirements and Standard Operating Procedures (SOP). Independently responsible for conducting preliminary reviews of local quality requirements from the Quality Management System (QMS). While performing reviews of scientifically intricate records, reports, and inspections of novel or complex processes to assure compliance with applicable regulatory requirements, international standards, and corporate policies and procedures. Understand the voice of the customer and make recommendations to the Quality Management. Take a lead role in executing continuous improvement initiatives as supported by QMS metrics and/or site management. At a minimum, 20% of this role’s responsibilities are customer-facing (e.g. customer audit participation and correspondences via email and telephone). Essential Duties And Responsibilities Assure Charles River’s compliance with applicable federal, state, and local regulations as well as corporate policies to avoid any business interruptions. Communicate all identified compliance and quality risks to management. Perform compliance assessments of site and cross-site Quality Systems (process inspections/facility inspections/equipment and record review/computer validation activities; and/or training records) including review of client audits. Provide recommendations to Operations and Quality Management for improvements in auditing of Quality Systems based on extensive knowledge and understanding of current regulatory inspection guidance and internal trends. Lead the preparation of study and QA files in preparation for client audits, sponsor site visits and regulatory inspections; assure that QA audit files are retained. May host client site visits and manage regulatory inspections. Along with the possibility of managing client inquiries, communications, and other audit related activities. Develop recommendations for corrective and preventative actions to respond to client visit and regulatory inspection findings. May coordinate the drafting of correspondence responding to client visits and regulatory inspections in conjunction with impacted departments. Report outcomes to upper management. Review/approve SOPs, protocols/batch records, reports or other quality and regulated records (e.g. deviations, change controls, or CAPA) involving technically complex issues or processes for accuracy and compliance with all applicable regulations and internal policies. Participate in corporate compliance assessments/mock-agency inspections of other Charles River (CR) sites. To ensure records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and procedures. Essential Duties And Responsibilites Lead the execution of Coordinated Facility Audits on a variety of QMS topics that impact multiple CR sites. Lead in updating training materials with applicable regulations or standards (ISO/GLP/GMP). Coordinating the performance and document site-wide training sessions. Take a lead role in supporting regulatory inspections. Perform qualification audits of subcontractors, as applicable. Lead the execution and scheduling of internal facility inspections at planned intervals to evaluate effective control and maintenance of site quality systems. Maintain written and signed records of all audits and inspections as required and may sign records documenting the performance of audits and inspections and reporting to management. Ensure the performance of facility, equipment records, and logbook reviews. Where appropriate, approve customer test reports and participate in reagent release activities to support laboratory operations. Support meeting the review and management of requirements for Customer or Supplier related Quality Agreements Conduct process based inspections as deemed necessary. Provide QA support in the validation of computer programs, controlled rooms, test methods, and manufacturing equipment. Identify any regulatory/standard (as applicable) risk areas and provide recommendations for corrective actions to upper management. Prepare and present the collection and reporting of site Quality Metrics via QMS. Facilitate, host, and present at Quality Management Review Provide recommendations for dashboard analysis and analyze metric data for QMS. Participate and/or take a lead role in coordination of Quality Assurance projects. Serve as a representative of Regulatory Compliance on harmonization teams. Serve as project manager on assigned multi-site projects. Provide training of Quality Assurance personnel with focus on QMS. Perform all other related duties as assigned. Qualifications Education: Bachelor’s degree (B.S. /B.A.) or equivalent, preferably in a life science. Experience: Minimum of 8 years in a Quality Assurance role or regulated industry. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Other: Experience with Microsoft Office® applications and spreadsheet/database programs such as Access and Excel. Position requires the individual to be able to communicate clearly, effectively and professionally; easily grasp instructions without follow-up; attention to detail and strong writing skills are essential. The pay for this position is $34.00 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 Microbial Solutions Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies. About Charles River Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in 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 companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2019, revenue increased to $2.62 billion. 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 supported the development of 80% of the drugs approved by the FDA in the last five years. 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 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, or 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 View email address on click.appcast.io. 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 237026 #J-18808-Ljbffr