Associate Quality Assurance Auditor

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.

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

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.

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 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.

The following are the minimum requirements related to the Associate Quality Assurance Auditor position.

• 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.

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.

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