Associate Quality Assurance Auditor

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
BASIC SUMMARY:
With guidance and oversight by Quality Assurance (QA) auditors, 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:
• Communicate all identified compliance and quality risks to supervisor.
• Assist auditors with data audits to assess that the records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and procedures.
• Assist auditors with the review of SOPs, protocols/batch records, reports, and other quality and regulated records for accuracy and compliance with all applicable regulations, international standards, and corporate policies and procedures.
• Prepare written and signed records of all audits and inspections as required and may sign records as a trainee, countersigned by supervisor/trainer, documenting the performance of audits and inspections and reporting to management.
• Assist auditors with preparation for sponsor site visits and the review of QA files; assure that QA audit files are retained.
• Assist auditors in identifying, documenting, reporting deviations from regulations, protocols/batch records, SOPs, and specifications.
• Perform a preliminary review of protocols/batch records and reports to assure accuracy, completeness, and compliance with regulations, international standards, and company policies and procedures.
• Assist auditors with routine monitoring of processes, facilities, equipment, personnel, materials, methods, practices, records, and controls to assure compliance with regulations and international standards.
• Perform all other related duties as assigned.
The hourly rate/range for this position is $24-$27/hour.
This position requires training (onsite). Future opportunity for Hybrid work (1-2 days a week).
Job Qualifications
QUALIFICATIONS:
• Education: Bachelor's degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline.
• Experience: 0-1 year experience (this is an entry-level/training position).
• 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.
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 supported the development of 86% of the drugs approved by the FDA in 2021.
Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to [email protected]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit www.criver.com.