Document Control Specialist 2

Document Control Specialist 2 Req ID #:  106153 Location: 

Newark, DE, US, 19711 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, we’ll help you build a career that you can feel passionate about.isabled/Vet Job Summary

Conducts quality system inspections to support all regulated work intended to support the company's business segments.

We are seeking a Document Control Specialist IIfor ourMicrobial site located inNewark, DE.

The following are responsibilities related to the Document Control Specialist II:

Provide support to the Charles River Pilgrim application and the Quality Management System (QMS). Serves as support on harmonized business segment projects.

The following are minimum qualifications related to the Document Control Specialist IIposition:

Coordinate the revision process of Standard Operating Procedures (SOPs), forms and other controlled documents. Responsible for organizing QA records and archiving. Maintain historical files for SOPs and forms through Pilgrim. Assure that site document management strategies and regulatory requirements for electronic documents are upheld. Enter, update and edit controlled documents and coordinate requirements for new documents with internal customers. Serve as the local system administrator for the Pilgrim application which includes but is not limited to the responsibility for establishing user accounts, assigning roles and access privileges. Responsible for QA record archiving and administrative support. Manage the daily flow and final release of controlled documents and training records through the Pilgrim application. Exhibit a thorough knowledge of the Pilgrim application; establish, maintain and provide leadership for strong local administration support. Serve as the back-up system administrator for Pilgrim serving all Charles River Microbial Solutions operations which includes responsibilities for establishing user accounts, assigning roles and access and privileges, Perform all other related duties as assigned.

QUALIFICATIONS:

Education: High school diploma or General Education Degree (G.E.D.) Associate’s degree (A.A./A.S.) preferred. Experience: 3 or more years related experience in data entry and document management. An An equivalent combination of education and experience may be accepted as a satisfactory Substitute for the specific education and experience listed above. Certification/Licensure: None Other: Advanced computer skills required. Computer literacy in word processing and Database record-keeping experience required. Basic knowledge of medical terminology preferred. Attention to detail and the ability to organize and prioritize work and meet deadlines Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer. Must regularly communicate with employees/customers; must be able to exchange accurate information. Must occasionally move about inside the office to access file cabinets, office machinery, etc.

About Microbial Solutions

Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.

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 14,000 employees within 80 facilities in 20 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 2018, revenue increased by 22% to $2.27 billion from $1.86 billion in 2017.

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 ~85% of the drugs approved by the FDA in 2018.

Equal Employment Opportunity 

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet

Nearest Major Market: Philadelphia

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