Quality Assurance Auditor I

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.

About the role

Perform audits of basic records and reports and inspections of routine processes to assure compliance with applicable GLP regulatory requirements.

Responsibilities

• Assure Charles River’s compliance with applicable GLP.
• 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, SOPs, and protocols.
• Review SOPs, protocols, reports, and other quality and regulated records for accuracy, completeness, and compliance with all applicable GLP regulations.
• Maintain written and signed records of all audits and inspections as required and sign records documenting the performance of audits and inspections and reporting to management.
• Identify deviations from GLP regulations, protocols and SOPs.
• Independently perform inspections to monitor processes, facilities, equipment, personnel, materials, methods, practices, records, and controls to assure compliance with GLP regulations.
• Assist in scheduling and tracking QA audits, inspections and procedures as requested.
• Perform all other related duties as assigned.

Requirements

• Associates Degree with 3-5 years of GLP environment experience (lab & data review) or Bachelors Degree with 1-2 years of QA experience.
• GLP experience is preferred.
• 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.
• Must be authorized to work in the United States without a sponsor visa, now or in the future.
• May require occasional domestic travel.

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.

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.

Pay

$53,000 per year.

About Safety Assessment

Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.

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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.