Charles River Laboratories International Inc
Computer Validation Quality Assurance Specialist
Req ID #: 27343
Location: Wilmington, MA, US, 01887
For nearly 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, well help you build a career that you can feel passionate about.
We are seeking a Computer Validation Quality Assurance Specialist for our Quality Systems Department located in Wilmington, MA.
This position is primarily responsible for quality assurance monitoring and auditing related to achieving and maintaining computerized systems in a validated state, including validation documentation, vendors, and Charles River sites to ensure compliance with industry standards and regulatory agency expectations. Additionally, responsibilities include creating and maintaining related computer validation SOPs and related training material.
The following are the minimum requirements related to the Computer Validation Quality Assurance Specialist position:
* Bachelors degree (B.A./B.S.) or equivalent in science or related discipline.
* 2-4 years related experience in a pharmaceutical, biotechnology and/or biomedical industry.
* Working knowledge of computer validation requirements in government regulations including FDA 21 CFR parts 11, 58, 211, and 820, OECDs and related multinational industry standards and requirements.
* 1-2 years experience in auditing or quality assurance
About Corporate Functions
The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement.
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 clients 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 peoples 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.
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Equal Employment Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet
Nearest Major Market: Boston
Job Segment: Developer, Biotech, Quality Assurance, Pharmaceutical, Technology, Science, Research
Charles River Laboratories International Inc
Website : http://www.criver.com
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 our families, friends and colleagues across the globe. Our collective efforts as One Charles River are the key to our success, and we know that every job and every person is important. Every day, each of us strives to make a difference in whatever way we can.