Vendor Quality Specialist II 1

Vendor Quality Specialist II 1 Req ID #:  201431 Location: 

US 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  Collaborate with the internal and external partners to support the vendor quality management process to support all sites from the corporate level. Establish quality agreements with vendors. Work with sites to drive continuous improvement efforts by assisting and performing vendor audits on behalf of all business units.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Act as a liaison between Procurement, Operations, Quality Assurance and vendors to ensure the use of approved vendors/suppliers at CRL facilities in compliance with standard operating procedures and applicable regulatory requirements.

• Prepare, review, and establish quality agreements with vendors in accordance with internal CRL standards or procedures and external regulatory requirements. • Perform vendor qualification audits for CRL business units as needed and prepare audit reports • Work with management and business partners to revise SOPs, as needed.

• Support business units for client visits and regulatory audit responses, as needed.

• Communicate with Global Quality Systems Management, Operations, and Quality Assurance representatives to discuss quality issues and ensure quality products and services for use at CRL facilities.

• Support management in developing and achieving strategic initiatives to support the Vendor Quality Management group.

• Work with the System Administrator to enhance functionalities and capabilities of the vendor audit management system. Job Qualifications • Education: Bachelor’s degree (B.A. /B.S.) in life sciences or Information Technology (IT) preferred or equivalent in a related discipline.

• Experience: 3 or more years of experience in Quality Assurance in the GMP/GLP environment. Vendor auditing experience is preferred.

• An equivalent combination of education and years of experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

• Other: Must be able to communicate with essential personnel from all business sectors, i.e., Quality & Regulatory Leadership, Procurement, Site Management, etc. Must be highly proficient in data analysis and using the Microsoft Office Suite. Proficiency in spreadsheets and presentation applications required. Working knowledge of metric driven programs preferred

About Corporate Functions 

The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement.

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, 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.

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