Quality Assurance Associate 1

Quality Assurance Associate 1 Req ID #:  114231 Location: 

Charleston, SC, US, 29407 For nearly 70 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 We are seeking a Quality Assurance Associate for our Microbial Solutions site located in Charleston, SC.  

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: Participate in internal facility/SOP procedural audits to obtain a clear understanding of the Quality Systems and regulatory requirements for the manufacturing/testing operations.  Participate in new employee orientation and associated GMP training to obtain an understanding of GMP regulations and site SOP requirements.

The following are the responsibilities related to the Quality Assurance Associate:

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.

•    Participate in internal audits of Quality Systems and processes to ensure compliance with GMPs and Standard Operating Procedures, including follow-up on corrective action implementation, and effectiveness.

•    Review incoming raw material receipt packages for compliance with the requirements detailed in material specifications and applicable testing procedures.

•    Determine and assure that exception documentation is appropriately reported and documented.

•    Prepare and sign Certificates of Quality related to depyrogenation of accessory products.

•    Prepare and review Quality Assurance files prior to Sponsor site visits.

•    Perform all other related duties as assigned.

  Job Qualifications The following are the minimum qualifications related to the Quality Assurance Associate :

•    Education:   Bachelor’s degree (B.S./B.A.) or equivalent, preferably in a life science or related discipline.

•    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.

•    Certification/Licensure: N/A

•    Other:  Knowledge of Microsoft Office ® applications and spreadsheet programs such as Access and Excel. This position requires the individual to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements and effectively communicate (written and oral) findings.

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 17,000 employees within 90 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 - M/F/Disabled/Vet

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  crrecruitment_US@crl.com . This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications .

Nearest Major Market: Charleston South Carolina

Nearest Secondary Market: South Carolina

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