Job 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.

Job Qualifications

• Education: Bachelor’s degree (B.A./8.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.
• Other: 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.
• Must occasionally move about inside the office to access file cabinets, office machinery, etc.
• May occasionally be required to wear protective clothing and equipment.

WORK ENVIRONMENT:

• General office working conditions and/or laboratory/manufacturing areas.
• The noise level in the work environment ranges from low to moderate.
• May occasionally  be required to work in tight or confined spaces.
• May occasionally  be exposed to high temperatures  and humidity.

COMMENTS:

• May require occasional domestic travel.

Compensation Data

The pay range for this position is $60,000 to $64,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.