Quality Assurance Auditor 1

Req ID #:  67552
Location: 

Wayne, PA, US, 19087

For 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 Auditor 1 for our Biologics Testing Solutions site located in Wayne, PA.

 

Under direct supervision, as well as independently, perform audits of a broad range of records and reports and inspections

of a variety of processes to assure compliance with applicable regulatory requirements, international standards and

corporate policies and procedures. In the GMP facilities, also responsible for approval and released of the finished product for distribution to clients.

 

The following are responsibilities related to the Quality Assurance Auditor 1:

 

•    Assure Charles River’s compliance with applicable federal, state and local regulations as well as corporate policies to

     avoid any business interruptions.  Communicate all identified compliance and quality risks to manager.
•    Perform data audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in

     compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and

     procedures.
•    Review SOPs, protocols, batch records, reports and other quality and regulated records involving technically

     complex issues and processes for accuracy and compliance with all applicable regulations and internal policies.
•    Maintain written and signed records of all audits and inspections as required and may sign records documenting

     the performance.

 

The following are minimum requirements related to the Quality Assurance Auditor 1 position:
 
•    Education: Bachelor’s of Science or Bachelor’s of Arts.
•    Experience:  2-4 years in a Quality Assurance role.

•    Certification/Licensure:  ASQ if applicable.

•    Other: Good working knowledge of Microsoft Office applications (e.g. Word, Access, Excel).  Good knowledge of

     applicable regulations and guidance documents; able to apply critical thinking skills to evaluate requirements.  

     Must be detail oriented and able to effectively communicate findings verbally and in writing.

 

About Biologics Testing Solutions

With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs.  Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

 

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 2018, 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