Associate Quality Assurance Auditor

About the Role

Charles River Labs based in Charleston, SC is seeking an Associate Quality Assurance Auditor within our Quality team. Shift is M-F 11:30 AM - 8:00 PM.

Responsibilities

The Associate QA Auditor will perform audits of quality control testing data for routine assays, incoming and in-process materials, process documentation, and labeling to assure accuracy and compliance with Good Manufacturing Practice Regulations (GMP) and Standard Operating Procedures (SOP). Additional responsibilities include:

• Review of Accessory Batch Records
• Participating in team activities such as pre-audit walkthroughs, data reporting, and additional tasks as needed

Essential Duties and Responsibilities

Under the training, mentorship, and review of senior Quality Assurance personnel, learn and apply the principles of GMP compliance to work assignments, including:

• Participate in the review of SOPs and other controlled documents for compliance with all pertinent GMP regulations and internal policies
• Perform raw data audits of documentation for temperature, humidity, and magnehelic gauges monitoring environmentally controlled areas, and autoclave/oven charts to ensure accuracy and compliance with applicable GMPs and Standard Operating Procedures
• Review incoming raw material receipt packages for compliance with the requirements detailed in material specifications and applicable testing procedures
• Review accessory product records for compliance with the requirements detailed in product specifications and applicable testing procedures
• Review instrument release packages for compliance with the requirements detailed in product specifications and applicable testing procedures
• Review equipment and process logbooks as required
• Perform all other related duties as assigned

Qualifications

• Associate’s degree (A.S./A.A.) or equivalent, preferably in a life science or related discipline
• Bachelor’s degree (B.S./B.A.) preferred
• 1-2 years of experience in a Quality Assurance role

Pay

The pay range for this position is $22-$23/hr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.

About Microbial Solutions

Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection, and microbial identification products and services designed to meet the complex and ever-changing needs of the industry. We help clients 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.

About Charles River

Charles River is an early-stage contract research organization (CRO) with a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, supporting clients from target identification through preclinical development. We also provide products and services for clinical laboratory testing and manufacturing activities. With over 20,000 employees in 110 facilities across 20 countries, we coordinate global resources to resolve unique client challenges. Our mission and strong sense of purpose guide us in improving the health and well-being of people worldwide.