Charles River Laboratories Quality Control Specialist - Lab Sciences Data Management in Mattawan, Michigan
Quality Control Specialist - Lab Sciences Data Management
Req ID #: 40244
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 a Quality Control Specialist for our Lab Sciences Data Management Team located in Mattawan, MI.
The Quality Control Specialist position is responsible for verification, reporting, and archival of study data and departmental records according to established Standard Operating Procedures (SOPs), protocols, methods, and processes. This individual will compile scientific reports in standardized formats and coordinate their delivery per established schedules. This individual works cooperatively with other departments to ensure documentation and reporting practices are consistent and compliant. This individual contributes to the department by working independently, completing assigned projects on time, participating in process improvement initiatives, and communicating effectively with others.
The following are the minimum requirements related to the Quality Control Specialist position.
MS/BS/BA in relevant field and 2-5 years of relevant experience; or
HS/GED/Associates and 5-10 years of relevant experience.
Prior experience in a regulated environment.
Proficiency with LIMS and data acquisition software for the generation of data summaries and reports.
Expert knowledge of GxPs and industry guidance documents.
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.
Proficiency with Microsoft Office Suite.
Ability to work under specific time constraints.
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 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 Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet