Charles River Laboratories Quality Assurance Auditor - Quality Assurance in Mattawan, Michigan
Quality Assurance Auditor - Quality Assurance
Req ID #: 36995
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.
We are seeking aQuality Assurance Auditor for our Quality Assurance Team located inMattawan, MI.
The Quality Assurance Auditoris responsible for: performing independent assessments of protocols, computer systems, laboratory procedures, data, documentation, and reports, to determine the level of compliance with applicable Good Laboratory Practice (GLP) Regulations, Standard Operating Procedures (SOPs), and study protocols. On occasion, the individual in this role may assist with Sponsor visits, may act as lead on Quality Assurance Unit (QAU)-initiated projects, and/or represent QAU on projects requiring QAU representation. The Auditor is a subject-matter expert (SME) resource to MPI Research personnel. Successful completion of the in-house QAU training program will be required.
The following are the minimum requirements related to theQuality Assurance Auditor position.
HS/GED/Associates degree and 5 or more years of relevant experience, and/or RQAP-GLP Certification; contract research organization (CRO) or pharmaceutical industry experience preferred; or,
Bachelor’s/Master’s degree in a relevant field and 2 or more years of relevant experience with training and experience related to GLP and food and Drug Administration (FDA) processes, and/or RQAP-GLP Certification; CRO or pharmaceutical industry experience preferred.
Proficient at performing data and report audits according to protocols, GLPs, and SOPs as applicable for at least 2 additional product lines or areas.
Basic knowledge of pharmaceutical research and development processes and regulatory environments.
In-depth knowledge and experience with FDA, EPA, OECD, and other regulatory requirements.
Demonstrated strong problem-solving skills, critical-thinking skills, organizational skills, and the ability to individually manage multiple projects and work under specific time constraints.
Excellent verbal/written communication skills and strong interpersonal skills.
Demonstrated ability to establish and maintain effective working relationships with coworkers, QAU management, and clients.
Basic familiarity with Microsoft Office Suite
Computer skills, commensurate with Essential Functions, including the ability to learn a validated system.
Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts; sometimes on short notice.
About MPI Research, a Charles River Company
MPI Research is a premier non-clinical contract research organization (CRO) providing comprehensive testing services to biopharmaceutical and medical device companies worldwide.
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 11,000 employees within 70 facilities in 18 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. And in 2016, revenue increased by 23.3% to $1.68 billion from $1.36 billion in 2015.
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 70% of the drugs approved by the FDA in 2016.
For more information, please visitwww.criver.com.
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet