Quality Assurance Specialist 1

Quality Assurance Specialist 1 Req ID #:  163871 Location: 

Raleigh, NC, US, 27610 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.

IMPORTANT:   In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.  Please make sure work history and education are added correctly. Job Summary  

We are seeking a Quality Assurance Specialist 1 to support our Quality Assurance Department for our  Research Model Services (RMS) location in Raleigh, NC.  

The Quality Assurance Specialist 1 is responsible for performing audits of basic records and reports and inspections of routine processes to assure compliance with applicable regulatory requirements, international standards, and corporate policies and procedures.

ESSENTIAL DUTIES AND RESPONSIBILITIES: Assures 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 supervisor.   Participates as the RMS-NA Vendor Program Committee representative for the Global Vendor Management Program and have responsibility for upkeep of Pilgrim vendor management database for RMS-NA. Performs 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 Reviews SOPs, protocols/batch records, reports, and other quality and regulated records for accuracy, completeness, and compliance with all applicable regulations, international standards, and corporate policies and procedures. Generates written and signed reports of all audits and inspections as required in accordance with QA SOPs.  Coordinates the preparation and review of data and QA files in preparation for client site visits; assure chain of custody of all records.  Hosts client site visits and support external inspections. Assists in the development of corrective action to respond to client inspections.   Identifies, documents, and reports deviations from regulations, equipment protocols, SOPs, and company policies. Reviews data, records and reports to assure accuracy, completeness, and compliance with regulations, international standards, and company policies and procedures. Independently performs inspections and audits to monitor processes, facilities, equipment, personnel, materials, methods, practices, records, and controls to assure compliance with regulations, SOPs, and company policies. Schedules and tracks QA audits, inspections and procedures as assigned by QA management. Participates in Regulatory Affairs and Compliance projects. MINIMUM QUALIFICATIONS: Bachelor’s degree (B.A./B.S.)  1+ years of experience in a QA or Auditing An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above Must have experience with comprehending regulations and guidance documents Proficient in Microsoft Office Suite (e.g. Word, Excel, Outlook) Detail oriented Communicates effectively both verbally and in writing Works independently Domestic and International Travel required - up to 30%

PREFERRED QUALIFICATIONS: ALAT Certification

IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 

Vaccine Mandate

Charles River is a U.S. Federal Contractor.  As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19.  Our main priority is the wellbeing, health, and safety of our people. We require proof of vaccination from all employees. 

Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.

About Research Models & Services 

Fundamental to basic research and discovery is the use of in vivo models to help identify disease targets and determine potential biological pathways that regulate the condition.  As the world’s leader in the production and distribution of the highest quality research animal, with 1 out of 2 animal models produced for preclinical research globally, we understand the importance of this step. With seven decades of experience, our expertise is unmatched, allowing us to provide you with the perfect model, including disease-specific and preconditioned options, for basic research and beyond. 

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 18,000 employees within 100 facilities in over 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. 

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 for the past 3 years.

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, 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 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.

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

Nearest Major Market: Raleigh

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