Quality Technical Reviewer - Celsis

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.

Primarily responsible for reviewing and approving GMP laboratory data and reports supporting microbiological studies for Celsis ATP Bioluminescence and other Microbial Solutions products. This on‑site position will be co‑located with laboratory personnel at the Charleston site for fostering a collaborative working relationship with laboratory peers. This position will actively integrate with the Quality and Regulatory Affairs leadership to support upholding a high‑quality standard in laboratory data.

As a peer and mentor to laboratory staff, this position may also assist with daily tasks of maintaining supply materials, laboratory tidiness activities, and will be continually trained on laboratory processes to maintain understanding during quality review duties.

• Is capable of understanding and applying requirements related to Alternative Microbiological Method Validation.
• Is a 100% on site position at this time for fostering a collaborative working relationship with laboratory peers.
• Understands and routinely applies Good Manufacturing Practices (GMP) towards reviewing laboratory data.
• Serves as a final Quality approver on Microbial Applications Lab reports.
• Serves as a Quality approver and collaborative resource for laboratory investigations.
• Has an ongoing understanding of various regulatory regulations as applicable to products tested in the Celsis laboratory.
• Maintain records compliance by adhering to regulatory guidelines set forth by the company and varying agencies.
• Assists with laboratory maintenance activities as appropriate.
• Perform all other related duties as assigned.

• Education
  :
  Bachelor’s Degree in a Biological or Chemistry Sciences discipline.
• Experience
  :
  At least 2 years working in a GMP-regulated environment.
• Certifications/Licensures:
  None
• Must be comfortable working collaboratively or individually
• High standards for integrity and quality of work performed

The pay range for this position is $65,000 to $80,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.

Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever‑changing needs of the industry. We help clients to ensure product safety and quality with easy‑to‑use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.

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 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…