Operational Software System Administrator

Req ID #:  187492
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.

Job Summary

Responsible for overseeing systems and database administration, infrastructure, and in-production applications support in.a cGMP regulated  environment, including software integration, LIMS, SAP middleware, internal/external networking, and other computer related functions. The system administrator will coordinate with management in alignment with the business objectives of the organization while performing day-to-day software and systems support and scheduled maintenance and liaising with quality and validation specialists on supporting validation documentation.

Job Qualifications

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Establish user requirements for software systems and support laboratory information system (LIMS)
  • Execute software projects and LIMS updates to meet timelines and business needs
  • Support internal and external software applications, computer systems and components, including LIMS and other software (both off-the-shelf and custom in-hour proprietary software)
  • Responsible for interfacing with the end user to gather requirements for bug fixes, maintenance/configuration updates, and application enhancements
  • Maintain validated systems using GAMP/cGMP guidelines
  • Responsible for interfacing with the end user to gather requirements for bug fixes, maintenance/configuration updates, and application enhancements
  • Proficient with Data Backup/Data Archiving requirements, and verifies that they are being carried out properly through documented periodic testing and verification
  • Manage the deployment, monitoring, maintenance, development, upgrade and support of all software systems· including overall database schema, user database access views, accessioning, pricing, sample tracking, file transfer, data analysis, instrument interfacing, report generation, report transmission, archiving and invoicing
  • Ensure solutions are transitioned smoothly through the production cut-over process
  • Lead training and/or ensure effective knowledge transfer to those responsible for training
  • Partner with software development team to develop and implement software development policies and procedures, including those for architecture, security, disaster recovery standards, purchasing and service provision
  • Assist in the development and implementation of process and systems improvements
  • Ensure adherence to pertinent regulatory requirements [SOX, FDA and GAMP guidelines] and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols]
  • Maintain understanding of Compliance/Data Integrity
  • Participate in customer audits as needed
  • Keep team knowledge base up-to-date
  • Maintain and manage all supporting system documentation
  • Responsible for identifying audit trails and content, and performing audit trail review
  • Manage user Account creation and account deactivation, password reset, and active status reset
  • Perform all other related duties as assigned

 

QUALIFICATIONS:

  • Education: Bachelor’s degree (B.A./B.S.) or equivalent in Computer Science, MIS, or related discipline.
  • Experience: 2 or more years’ experience in system administration, information systems, or related field – experience in a combination of scientific, IT or business domains is preferred.
  • Certification/Licensure: None
  • Other: Genuine interest or experience in life science technologies and applications is preferred.

 

 

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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