QA Computer Systems Validation Specialist

Req ID #:  140352
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

Responsible for providing Quality oversight, collaboration, review, and approval of Computerized System Lifecycle validation deliverables as directed. Reviews and approves validations/qualification documents per Standard Operating Procedures (SOPs) and regulatory guidelines.  

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:  

  • Provide quality oversight, review and approve qualification, validation and verification deliverables of laboratory instrumentation software systems and change control for software modifications 
  • Support client and regulatory inspections
  • In conjunction with end users and operations staff, ensure an efficient, compliant, testing, qualification and validation process is effective 
  • Assist with ongoing analysis of laboratory computerized systems validation activities, that align with regulations, policy and industry accepted best practices
  • Participate in a team setting to refine and harmonize computerized systems qualification processes and templates
  • Assist end user in the production of computerized systems test & plans as applicable
  • Coordinates and communicates all testing with affected functional groups and evaluate test results
  • Perform document reviews and update applicable SOPs
  • Work with leadership to ensure equipment, facility, utility, computer system, and Automated Process Control validation studies include:
    • protocol preparation,
    • scheduling,
    • protocol execution,
    • data and compose
  • Assist with external audits to support CSV vendors
  • Participate with Change Control initiatives as related to computer systems
  • Ensure adherence to pertinent regulatory requirements, departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols]
  • Support the policy of equal employment opportunity through affirmative action in personnel actions.
  • Perform additional duties as assigned.

 

MINIMUM QUALIFICATIONS:

  • Bachelor’s degree (B.A./B.S.) or equivalent in computer science, scientific or related discipline  
  • 2-4 years related experience as a quality reviewer in test management, validation, regulatory compliance to include a GMP/GxP laboratory is preferred
  • Knowledgeable in the areas of 21 CFR 210, §211, and Part 11, GAMP5, EudraLex Annex 11 Volume 4 - Computerized Systems 
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • Certification/Licensure: Test or validation certification preferred
  • Required to work within lab areas


 

 

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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