Job Summary
We are seeking a Quality Assurance Auditor 1 for our Quality Assurance Department located in Shrewsbury, MA.
The Quality Assurance Auditor 1 is responsible for performing audits of basic records, reports and inspections of routine processes to assure compliance with applicable regulatory requirements, international standards, and corporate policies and procedures. Other key responsibilities related to this role include:
- Assure Charles Rivers 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.
Job Requirements
The following are the minimum requirements related to the Quality Assurance Auditor 1 position:
- Bachelors degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline.
- Minimum 1 year auditing experience in a GMP QA role.
- Knowledge of Microsoft Office applications.
- Must be able to comprehend regulations, documents and apply critical thinking skills.
- Must be detail oriented, communicate effectively verbally and in writing.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
About Corporate Functions
The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement.
With over 14,000 employees within 80 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our clients unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2018, revenue increased by 22% to $2.27 billion from $1.86 billion in 2017.
At Charles River, we are passionate about our role in improving the quality of peoples 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 ~85% of the drugs approved by the FDA in 2018.
Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet