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Quality Assurance Specialist 2 (Auditor)

Charles River Laboratories International Inc (CRL)

Wilmington, MA, US, 01887

Quality Assurance Specialist 2 (Auditor) Req ID #:  134231 Location: 

Wilmington, MA, US, 01887 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 2, Research Model Services (RMS) for our Quality Assurance Department located in Wilmington, MA. 

(Some remote work will be available.)

 

 

The Quality Assurance Specialist 2  is responsible for independently performing 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 company 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. 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 involving technically complex issues and processes for accuracy and compliance with all applicable regulations and internal policies. Generates written and signed reports of all audits and inspections as required in accordance with QA SOPs. Review audit reports as assigned.  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. Coordinates in the development of corrective action to respond to client inspections. Identifies, documents, and reports deviations from regulations, equipment protocols, SOPs, and company policies. Provides recommendations to Regulatory Affairs and Compliance management for improvements in auditing of Quality Systems based on knowledge and understanding of regulations and quality principles. Reviews data, records and reports to assure accuracy, completeness, and compliance with regulations, international standards, and company policies and procedures. Leads inspections and audits of subcontractors, vendors, and suppliers of products and services. Assists in scheduling and assigning QA audits, inspections and procedures as assigned by QA management. Serves as the RMS-NA Vendor Program Committee backup representative for the Global Vendor Management Program

  MINIMUM QUALIFICATIONS: Bachelor’s degree (B.A./B.S.)  2+ years of experience in a QA or Auditing role in a research environment or Animal Facility/Vivarium 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 10%

 

PREFERRED QUALIFICATIONS: Bachelor's degree (B.A./B.S) preferably in life science  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. 

 

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 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.

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

Nearest Major Market: Boston

Job Segment: Biotech, Pharmaceutical, Laboratory, Quality Assurance, Science, Research, Technology

Job posted: 2021-10-20

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