Quality Assurance Auditor 1

Req ID #:  140955
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.

Basic Summary

Perform 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:

  • 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 supervisor.
  • 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 for accuracy, completeness, and compliance with all applicable regulations, international standards, and corporate policies and procedures.
  • Maintain written and signed records of all audits and inspections as required and may sign records documenting the performance of audits and inspections and reporting to management.
  • Participate in the preparation and review of study/batch record and QA files in preparation for sponsor/client site visits; assure that QA audit files are retained.
  • May participate in the hosting of client site visits and support regulatory inspections.
  • Participate in the development of corrective and preventative actions to respond to client visit and regulatory inspection findings.
  • Identify, document, and report deviations from regulations, protocols/batch records, SOPs, and specifications.
  • Review protocols and batch records and reports to assure accuracy, completeness, and compliance with regulations, international standards, and company policies and procedures.
  • Independently perform inspections and audits to monitor processes, facilities, equipment, personnel, materials, methods, practices, records, and controls to assure compliance with regulations and international standards.
  • Participate in inspections and audits of subcontractors, vendors, and suppliers of products and services.
  • Inspect materials and supplies for compliance with specifications.
  • Assist in providing basic regulatory training to operations personnel.
  •  Assist in scheduling and tracking QA audits, inspections and procedures as requested.
  • Maintain written records for all statistical sampling and testing of product if tested in manufacturing areas.
  • Participate in manufacturing line clearances and verification of room acceptability prior to product manufacture.
  • Participate in Regulatory Affairs and Compliance projects.
  • Perform all other related duties as assigned.
     

MINIMUM QUALIFICATIONS

  • Bachelor's degree (B.A./8.S.) or equivalent, preferably in a life science or related discipline.
  • 1-2 years experience in QA role
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • Knowledge of Microsoft Office applications (e.g. Word, Access, Excel). Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements.
  • Must be detail oriented and able to effectively communicate findings verbally  and in writing.

 

PHYSICAL DEMANDS:

  • Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer.
  • Must regularly communicate with employees/customers; must be able to exchange accurate information.
  • May occasionally be required to wear protective clothing and equipment.

WORK ENVIRONMENT:

  • General office working conditions and/or laboratory/manufacturing areas.
  • May occasionally  be required to work in tight or confined spaces.
  • May occasionally  be exposed to high temperatures  and humidity.
  • May require occasional domestic travel.

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 by December 8, 2021.  Our main priority is the wellbeing, health, and safety of our people. We will be requiring 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 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 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 - 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: Philadelphia

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