Associate Quality Assurance Auditor

2 weeks ago

Charleston, United States Charles River Laboratories Full time

Associate Quality Assurance Auditor (2nd Shift)

Req ID #: 222862

Location:

Charleston, SC, US, 29407

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

Charles River Labs based in Charleston, SC is seeking an Associate Quality Assurance Auditor within our Quality team.

The Associate Quality Assurance (QA) Auditor is an entry level trainee position.

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.

Job Qualifications

Education

• 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.

Experience

• Entry level - 0+ year experience.

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

Skills and Abilities

• Knowledge of Microsoft Office ® applications and spreadsheet programs such as Access and Excel.

• Team Player, able to provide input into a multifunctional team, while demonstrating the ability to work independently.

• This position requires the individual to comprehend regulations and guidance documents and apply critical thinking

• Possess a strong communication skill, including written, verbal and presentation in English.

• Strong time management and ability to prioritize.

Compensation

The pay range for this position is $40-55K annually. 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 ~85% of the drugs approved by the FDA in 2019.

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.

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

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