QA Computer System Validation Specialist
Charles River Laboratories International Inc (CRL)
Wayne, PA, US, 19087
QA Computer System Validation Specialist Req ID #: 206792 Location:
Wayne, PA, US, 19087 For 75 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. Basic Summary We are seeking a QA Computer Systems Validation (QA-CSV) Specialist for our Biologics Testing Solutions site located in Wayne, PA.
You may be required to work a rotating shift schedule that may require weekend hours.
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 Validation Documentation including but not limited to: Validation Master Plan, User Requirements, Functional Requirements, Installation Qualification, Operational Qualification, Performance Qualification, Trace Matrix, Validation Summary Reports and Change Controls Support client and regulatory inspections Ability to work closely with multiple disciplines, including Manufacturing, Validation, Facilities, and Laboratories to support validation activities. Assist with ongoing analysis of laboratory computerized systems validation activities, that align with regulations, policy and industry accepted best practices Provide QA support to enforce CSV guidelines, policies and procedures for control systems, automation, analytical equipment, and IT applications Experience in writing & reviewing SOPs and protocols for accuracy and compliance Ensure site systems are compliant with the corporate Data Integrity program Participate with Change Control initiatives as related to computer systems. Support the Computerized System Validation Lifecycle to ensure compliance to 21 CFR Part 11, EudraLex Annex 11, and applicable FDA/EMA Guidance's on electronic data integrity. Participate in site and corporate quality and process improvement initiatives 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 Exceptional understanding of data governance and ALCOA principles. 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
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 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 20,000 employees within 110 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 86% of the drugs approved by the FDA in 2021.
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 [email protected] 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
Job Segment: Pharmaceutical, Laboratory, Quality Assurance, Computer Science, Science, Technology, Research
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