Quality Assurance Auditor 1 - Analytical 1
Req ID #: 57412
Location:
Mattawan, MI, US, 49071
For 70 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 aQuality Assurance Auditor 1 for ourAnalytical Quality Assurance Group locatedMattawan, MI.
The following are responsibilities related to the Quality Assurance Auditor 1:
A Quality Assurance (QA) Auditor I is responsible for performing 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.
The following are the minimum qualifications related to the Quality Assurance Auditor 1 position:
• Bachelor's degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline.
• 1-2 years experience in QA GLP role.
• 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.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Competencies
Collaborate -We collaborate when we partner with each other and promote teamwork, when we communicate clearly and effectively across the hall or around the globe, and when we welcome all forms of diversity and encourage inclusiveness.
Own - We act like owners when we hold ourselves accountable for our actions, when we respond to internal and external client needs with speed and accuracy, when we set and achieve meaningful goals, and when we strive towards continuous improvement.
Care - We show we care when we respect each other, our animals and the communities where we work and live, when we create a positive healthy workplace, when we are mindful of our compliance standards, and when we choose to do the right thing.
Lead - We lead when we advocate our purpose and model our values, when we deliver innovation, when we embrace change, and when we appreciate and celebrate the great work of others.
About Safety AssessmentCharles 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 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.
About Charles RiverCharles 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 13,000 employees within 80 facilities in 23 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 80% of the drugs approved by the FDA in 2017.
For more information, please visitwww.criver.com.
Equal Employment OpportunityCharles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet.