QA Auditor I

**Req ID #**:219028**Location**:Shrewsbury, MA, US, 01545- 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.**Job Summary**
We are seeking a
** QA Auditor I** for our Biologics Testing Solutions site located in Shrewsbury, MA. In this role you 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. 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.
- 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.
- **Job Qualifications**Education: Bachelor’s degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline.
Experience: 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.
Certification/Licensure: None.
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**The pay range for this position is $55,000-$60,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.”**

**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 test