Supplier Quality Engineer

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

This position reports to the Associate Director Regulatory Affairs and Compliance and will be responsible for supporting the improvement, implementation and continuous maintenance of the Supplier Quality Management Program.

This position will also collaborate with key internal and external (i.e. clients) business stakeholders and work cross functionally on continuous improvement activities to drive effective, compliant, and sustainable solutions / outcomes.

Incumbent will apply quality management and continuous improvement theory, technical principles and expert judgment to proactively assist the business in the identification of potential risk.

Incumbent will lead activities to ensure mitigation, improve compliance and enhance performance of key Quality activities.

Core to these activities will be the ability to effectively manage projects and foster effective interdepartmental and cross-functional partnerships.

• Develop, improve and maintain the Supplier Quality Management Program.
• Lead, support, and / or perform activities in the following areas : Supplier Audits, Supplier Qualifications / Re-qualifications, Supplier Corrective Action Reports (SCARs), Internal Corrective Action / Preventative (CAPAs), Non-Conformances (NCs), Change Controls, and Training.
• Compile and report key performance indicators (KPIs), metrics and compliance status of Supplier Quality Management Program for Quarterly Management Review (QMR), Weekly Site Performance and other Quality Systems as needed.
• Communicate weekly with manager on KPIs for Vendor Management.
• Maintain the Approved Supplier List (ASL) in the Electronic Data Management System (EDMS).
• Maintain the supplier scorecard.
• Create and maintain supplier audit schedule.
• Provide exceptional customer service to Cognate’s internal and external customers in all assigned tasks and foster a GMP compliant culture.
• Establish a continuous improvement program through the use of Total Quality Management (TQM) techniques.
• Ensure compliance to quality policies, procedures, and governing regulations.

Job Qualifications

• Bachelor’s degree in Life Sciences, Engineering or related field with minimum three (3) years experience in a biologics, biotechnology, pharmaceutical, medical device, or related industry OR Associates degree in Life Sciences, Engineering or related field with minimum five (5) years experience in a biologics, biotechnology, pharmaceutical, medical device, or related industry.
• Six Sigma experience or certification and / or Supplier Quality Engineer certification desired, not required.
• Ability to work independently and in a group on a variety of projects.
• Ability to maintain a high degree of accuracy and attention to detail.
• Ability to handle a fast-paced, multi-tasking environment, and prioritize effectively.
• Competency with electronic document managements systems, preferably MasterControl.
• Proficiency in Microsoft Office (Word, Excel, Outlook, etc.).
• Prior experience SOP, and or Procedure Development writing.
• Excellent written and oral communication skills with a thorough knowledge of grammar, spelling and punctuation.

The pay range for this position is $85,000 - $89,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

About Biologics Testing Solutions

With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide.

Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products.

Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs.

Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

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.