Charles River Laboratories · 18 hours ago
QA Auditor I
Malvern, PA
Full-time
Onsite
Entry Level
$60K/yr - $60K/yr
1+ years expCharles River Laboratories is a contract research organization dedicated to improving the health and well-being of people globally. The QA Auditor I role involves performing audits and inspections to ensure compliance with regulatory requirements and corporate policies, as well as participating in the development of corrective actions for compliance issues.
BiotechnologyHealth CarePharmaceutical
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
Qualification
Required
Bachelor's degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline
1-2 years experience in QA role
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
Benefits
Bonus/incentives based on performance
401K
Paid time off
Stock purchase program
Health and wellness coverage
Employee and family wellbeing support programs
Work life balance flexibility
Company
Charles River Laboratories
At Charles River, we are guided by our strong purpose—to create healthier lives—which centers around the patients who rely on the therapeutics we help to develop, the animals in our care, to our planet, and to the passionate and skilled people who are at the heart of our organization and make it all possible.
10001+ employees
H1B Sponsorship
Charles River Laboratories has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (53)
2024 (37)
2023 (41)
2022 (41)
2021 (19)
2020 (19)
Funding
Current Stage
Public CompanyTotal Funding
$1.54BKey Investors
The Foundation for Chemistry Research and Initiatives
2024-06-11Grant· $1.3M
2021-03-23Post Ipo Debt· $1B
2019-10-21Post Ipo Debt· $500M
Leadership Team
James C. Foster
Chairman, President & Chief Executive Officer
C
Chuck Moran
Associate Director, Digital Experiences and Marketing Technology
Recent News
2026-01-22
2026-01-22
Company data provided by crunchbase