Bethesda, MD, US
Quality Assurance Specialist
Job Type: Onsite
Job ID: 222936_en_US
Category: Quality and Regulatory Compliance
Department:
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 Summary
We are looking for a Quality Assurance Specialist to join our Insourcing Solutions team located in Bethesda, MD.
As the Quality Assurance Specialist, you will inspect and audit operations procedures, reports, facilities, equipment, documentation and personal adherence to protocols and SOPs.
Additional responsibilities include:
• Review and follow the NIAID Statement of Work (SOW) and Standard Operating Procedures (SOP) for compliance.
• Inspect for risk/hazard assessments to ensure staff safety. Assist in the training of all staff regarding the quality assurance and control process. Assist in supporting the NIAID Quality Control Plan deliverable. Compile findings and generate reports on trends and areas for improvement and training.
• Schedule and conduct audit and inspections of facility inspections and procedures for compliance with internal standard operating procedures, and study protocols.
• Review quality assurance records, reports and training records for accuracy and compliance with all applicable regulations and client guidelines
• Compose and submit written records of all inspections within the required timeframe.
• Enter, update edit quality assurance files and records and training resources.
• Develop and present quality assurance training for staff. Review and evaluate effectiveness of training presented.
• Assist in maintaining the Quality Control Plan by monitoring for completion, scheduling, and timeframes of various operational tasks.
• Comply with health standards of supporting contracts and company health programs.
• Ensure optimal performance of the quality assurance function by recommending and implementing techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain superior practices.
• Maintain required attendance level and adherence to work schedule in accordance with required staffing levels to ensure that assigned duties are completed.
• Perform other related duties as assigned.
Job Qualifications
Job Qualifications
• Education: Bachelor’s degree, preferably in a life science or related discipline.
• Experience: Two (2) years in a Lab Animal Quality Assurance role or Lab Animal management role with QA as a responsibility.
• An equivalent combination of education and experience may be accepted as satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure: None
The pay range for this position is $35 to $40 USD per hour. Please note that salaries vary within the range based on factors including experience, skills, education, certifications, and location.
About Insourcing Solutions
Charles River Insourcing Solutions℠ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment. Insourcing Solutions℠ provides you with the ability to maintain control of your facility and expertise while leveraging available space.
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 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 companies, 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 supported the development of 86% of the drugs approved by the FDA in 2021.
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.
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.
