Quality Assurance Professional - Analytical
Req ID #: 36852
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 e perform. In return, we'll help you build a career that you can feel passionate about.
We are seeking an experienced Quality Assurance Professional - for our Quality Assurance - Analytical Team located in Mattawan, MI.
A Quality Assurance Professional is responsible for performing Quality Assurance (QA) functions that assure the GLP compliance of MPI Research facilities & sites, including regulated studies & projects performed at MPI Research, and reporting the results of these functions, including all findings & recommendations, to management. MPI Research QA management has divided these responsibilities into three specialist groups: study/ project team, facility/ compliance team, & Sponsor/ subcontractor team. Cross-utilization may be executed as required & following appropriate training. The QA functions include, but are not limited to, independent, and at times subjective, assessments of protocols, system validation records, system use, laboratory procedures, equipment records, training records, data, and reports to determine the level of compliance with applicable domestic and foreign Good Laboratory Practices (GLP) Regulations, SOPs, policies (POL), and study protocols.. In addition, may be responsible for assisting management by participating in the training of new auditors, qualifying subcontractors, and hosting Sponsor visits.
The following are minimum requirements of the Quality Assurance Professional position:
- Bachelor's degree in relevant field and 8 years of relevent experience; or
- HS/GED and 10 years of relevant regulatory auditing experience.
- Basic familiarity with Microsoft Office Suite.
- Computer skills, commensurate with Essential Functions and including 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.
- Ability to work under specific time constraints.
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 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 120 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 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.
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet
Nearest Major Market: Kalamazoo
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