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 QC Specialist I for the QC Microbiology Department will be responsible for reviewing laboratory data, writing laboratory and environmental monitoring excursion reports, and executing simple tasks within projects / CAPAs / Change controls.

The position requires the utmost attention to detail, good organizational skills, computer proficiency, and a basic understanding of microbiology and laboratory instrumentation.

In addition, effective communication skills and the ability to function in a fast-paced, highly technical environment with minimal supervision are essential for success.

ESSENTIAL DUTIES AND RESPONSIBILITIES :

• Utilize electronic laboratory data systems (ie MODA) to effectively review data and / or generate data reports
• Initiate deviations and write simpler deviation reports to closure
• Initiate environmental monitoring excursions and drive simpler reports to closure
• Participate in relevant Change Control and CAPA tasks to drive completion of projects
• Adheres to standard operating procedures and good documentation practices to ensure data integrity and traceability
• Responsible for assisting with laboratory documentation upkeep and organization
• Utilizes GMP systems such as MODA and other laboratory computer systems
• Perform all other related duties as assigned.

Job Qualifications

• Bachelor's degree in biology or relevant scientific discipline preferred
• Minimum 1 years relevant laboratory experience or experience in a cGMP and / or FDA regulated industry or a combination of education and related work experience required
• Demonstrated knowledge in Good Documentation Practices and experience with laboratory data review
• Experience with electronic laboratory system (ie MODA) preferred
• Ability to work independently or as a team member

The pay range for this position is $44,000 - $50,000. 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.

Last updated : 2024-04-28