Associate Quality Systems Specialist 1

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
The Microbial Solutions team at Charles River Labs is seeking a Quality Assurance Auditor at our site in Newark, DE.
The hours for this position are Monday - Friday 1000- 1830 Eastern Time Zone hours.
This position requires flexibility and the ability to work overtime to support business needs.
Basic Job Summary
The QA Auditor will perform final review of basic records, reports, and inspection of sampling processing as well as conduct final release in compliance with applicable regulatory requirements, and corporate policies and procedures.
Essential Duties and Responsibilities
• Review and approve test results.
• Perform QC release of specified reagents and raw materials.
• Report all quality control issues, including but not limited to: OOSs, deviations, observations affecting processes, consumable/ vendor quality, equipment calibration, and training issues to the Quality Manager.
• Collect and organize data for all laboratory investigations.
• Collect and organize laboratory validation data.
• Provide technical support for internal audits.
• Maintain laboratory safety standards and requirements.
• Adhere to all laboratory SOPs.
• Participate in internal facility/SOP procedural audits to obtain a clear understanding of the Quality System and regulatory requirements for the testing operations.
• Recommend and implement improvements for procedures and protocol.
• Adopt work procedures and processes that support company and departmental standards, procedures, and strategic directives.
• Participate in associated GMP training to obtain an understanding of GMP regulations and site SOP requirements.
• Perform all other related duties as assigned.
Job Qualifications
• Education: Bachelor's degree (B.A./B.S.) or equivalent in Microbiology or related field.
• Experience: 0 - 3 years laboratory experience.
• Experience with FDA and international Quality System rules and regulations, including planning and implementation, is preferred.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure: None.
• Other: Must have working knowledge of the Quality System. Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements.
• Must be detail oriented and able to effectively communicate findings verbally and in writing.
Compensation Data
The pay range for this position is $42- 45K USD. 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 ~85% of the drugs approved by the FDA in 2019.
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 [email protected]. 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.