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Charles River Laboratories Document Control Specialist I- $750 sign-on bonus in Shrewsbury, Massachusetts

Document Control Specialist I- $750 sign-on bonus

Req ID #: 107771

Location:

Shrewsbury, MA, US, 01545

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.

Job Summary

Provide support to the Charles River document management applications and Quality Management System (QMS) processes. May provide support on harmonized business segment projects.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Coordinate the revision process of Standard Operating Procedures (SOPs), forms and other controlled documents.

  • Assist in organizing QA records and archiving.

  • Maintain historical files for SOPs, forms and other controlled documents.

  • 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 Charles River document management applications which includes responsibilities for establishing user accounts, assigning roles and access and privileges.

  • Assist in QA auditors with QA record archiving and administrative support.

  • Manage the daily flow and final release of controlled documents through the document management system.

  • Perform all other related duties as assigned.

MINIMUM QUALIFICATIONS:

  • High school diploma or General Education Degree (G.E.D.)

  • One to 2 years related experience in data entry and document management.

  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

  • Basic 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 required.

  • Strong written and verbal communication required to exchange accurate information.

About Biologics Testing Solutions

With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

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 17,000 employees within 90 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 2019, revenue increased to $2.62 billion.

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 2019.

Equal Employment Opportunity

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

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.

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