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QC Associate I

4 months ago

Rockville, Maryland, United States Charles River Laboratories, Inc. Full time

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

At Charles River Laboratories, we are looking for a highly motivated and energetic candidate to join our growing business in the CMO industry. The QC Associate I – Environmental Monitoring will perform microbiological testing, static and dynamic viable and non-viable monitoring of classified clean room areas to support planned or in process manufacturing processes. This position, as well as all positions in the Charles River team will require demonstration of Charles River DNA "Characteristics and Behaviors" (Care, Lead, Own and Collaborate).

Key Responsibilities and Duties:


• Performs viable and non-viable environmental monitoring in a static and dynamic environment.

• Perform water quality analysis testing such as TOC and conductivity testing.

• Demonstrate excellent aseptic technique and clean room gowning practices required for working in Grade C, B and A spaces.

• Perform bioburden testing per current cGMP guidelines to facilitate in process product development and raw material release.

• Perform growth promotion, microbial identification, pure colony streak plate isolation, biological indicator testing in a controlled BSL2 environment.

• Complete relevant data entry requirements in accordance with current data integrity expectations and the ALCOA principals

• Assist in laboratory investigations, environmental monitoring excursions and deviations.

• Participate and facilitate on-going lab excellence initiatives as directed by the Senior QC Analyst or area management.

• Must be able to pass visual acuity examination, including colorblindness, to perform visual inspection of drug products.

• Core hours for this position will be Thursday through Sunday, 0800 to 1800.

Job Qualifications


• B.S in Biology or related field

• 1-2 years working in a GMP facility is preferred, although not required.

• Able to lift up to 40 pounds

• Able to work in a clean room suite while wearing appropriate gowning and PPE

• Excellent verbal and written communication skills

• Ability to work independently or within a team setting

Compensation Data

The pay range for this position is $ $25.35 per hour. 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 [email protected]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

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