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 III will be responsible for participating and leading in workstreams such as QC Data reporting and trending, EM Data review, CAPA projects, Technical writing, and / or Laboratory Equipment maintenance.

QC Specialist III should have a clear understanding of Microbiological sampling / testing concepts, lean principles, GMP training program requirements, and laboratory equipment requirements.

This role plays a pivotal part in maintaining efficiency and compliance while collaborating across departments to ensure the timely and successful execution of project activities.

• Serves as lead for workstreams that includes but not limited to the QCM Training program, Laboratory Equipment Lifecycle, EM Data Trending, and / or Laboratory Compliance (Deviations, CAPAs, Change Controls, etc)
• Lead and assist in managing the training program for QC Microbiology Lab
• Faciliate the Induction, decommissioning, and calibration of laboratory equipment
• Participate in external client calls / meetings
• Performs laboratory data review for product disposition
• Write minor / major investigations and / or create / generate CAPA and Change Control projects
• Take initiative to execute continuous improvement project for the laboratory
• Perform data trends for Environmental Action Committee meeting and drive / oversee action items to completion
• Performs data / statistical analysis, data trending, reporting results and presenting data in group and client meetings (eg Quality Management Review).
• Excellent writing skills. Ability to draft Standard Operating Procedures (SOPs), protocols, reports, etc. Ability to write deviations, EARs, OOS reports, CAPAs.
• Interact closely with other departments to ensure efficient, compliant and timely execution of project activities
• Perform all other related duties as assigned.

Job Qualifications

• Bachelors or higher degree in the biological sciences or related field preferred with a minimum of 3 years of relevant laboratory experience in a cGMP and / or FDA regulated industry OR a combination of 5-7 years of education and laboratory experience in a cGMP and / or FDA regulated industry
• Experience with training laboratory personnel
• Experience with writing laboratory reports and / or investigations
• Experience with initiating and executing laboratory projects for continuous improvement
• Demonstrate strong leadership skills in a microbiological laboratory setting preferred
• Prior pharmaceutical, CMO, CDMO and hazardous goods experience preferred
• Familiar with laboratory data systems such as MODA, LIMS, etc preferred
• Experience with Microsoft Word, Excel and Outlook
• Detail oriented with strong written and verbal communication skills
• Experience with training laboratory personnel

The pay range for this position is $64,000- $70,000. 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.

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.

Last updated : 2024-05-25