Associate Quality Assurance Auditor

Charles River Laboratories; Charleston (SC); On-site; USD 30,000 - 32,000; Full time

Job summary

Charles River Laboratories in Charleston, SC is seeking an Associate Quality Assurance Auditor to join 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 GMP regulations and SOPs. You will review batch records and participate in pre-audit walkthroughs, data reporting, and related tasks.

Qualifications

• 1-2 years of experience in a Quality Assurance role.
• 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.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

Responsibilities

• 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.

Skills

Quality Assurance experience

Education

Associate degree or equivalent

Bachelor's degree preferred

Job description

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 Overview

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.

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 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

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.

An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

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 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.

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 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. And in 2019, revenue increased to $2.62 billion.

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 80% of the drugs approved by the FDA in the last five years.

We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

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.

It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

For more information, please visit www.criver.com.