The LIMS System Analyst will join a leader in infusion therapy and pain management who develops, manufactures, and markets innovative medical products and services to the healthcare industry and assist with understanding their current system requirements and assisting with system maintenance. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis.
The LIMS Systems Analyst is responsible for ensuring the LIMS is implemented and maintained in a state of compliance, meeting current regulatory expectations and in accordance with industry best practices.
The day to day responsibilities include:
- Designing, analyzing, implementing and supporting the LIMS computer systems and solutions based on the business requirements defined within the organization
- Developing and maintaining essential procedures and processes for supporting systems of medium to high complexity.
- Performing system analysis including completing requirement definitions, interfacing with business groups and providing cost and benefit analysis.
- Participating and leading new technology evaluations related to Laboratory informatics systems, hardware, management tools and methodologies.
- Identifying alternative or new laboratory informatics technologies and assisting with defining new global and regional standards.
- Managing the projects for implementation of new functionality or system upgrades.
- Maintaining Lab Systems knowledge, including staying current on software capabilities and availability of new functionality and updates from the software and hardware/instrumentation vendor.
- Assisting with applying lab systems updates, submitting product support requests, and performing system maintenance
- Ensuring accuracy and completeness of data and implementing process/procedural improvements
- Serving as a backup point of contact for technical support; establishing and maintaining security and integrity controls including documentation of such.
- Maintaining familiarity with QC Lab industry best practices and company specific change control SOPs.
- Completing Lab systems administration and management training to assure understanding of technology and techniques required to implement and support systems.
- Creating and revising lab system procedures and documentation.
- Interfacing with internal customer teams required for the successful deployment and maintenance of lab systems (validation, Instrumentation experts, etc.).
- Supporting lab systems site internal and external audit requests.
- Supporting the infrastructure used to deploy the Enterprise Laboratory Platform document site specific use of the deployed ELP system.
- Troubleshoot, identify problems, and provide advice to assist system users on course of action(s) needed through standard scripts/checklists.
- Ability to be on call for end user support by phone or on site 24 hours, 7 days a week
- Communicating any specific issues that affect users on a large scale.
- Reviewing validation documentation for specific computer systems, Quality equipment/process control systems and computer networks, to include validation plans, system requirements, design and validation protocols/reports
- Supporting audits of computer system, software and service suppliers
- B.S in Scientific discipline or Information Technology
- 7+ years of laboratory experience
- Minimum of 3+ years experience in lab systems administration
- 5+ years experience in a quality role required
- Experience partnering with cross functional departments
- Proficiency in building, configuration, implementation, and administration of QC lab systems.
- Familiar with current data integrity expectations, 21CFR Part 11
- Project Management experience
- Experience with GMP including US and EU regulations.
- Extensive experience in evaluating and implementing computer systems.
- Project leadership and systems analysis, including cost and benefit analysis.
- Advanced Degree (M.S., M.B.A)
Founded in 2013, I.T. Works Recruitment Inc. (ITWR) has grown to be the number 1 recruitment firm of choice for placing niche IT experts across North America. Our clients use high-tech software systems to facilitate all aspects of their business and identify as users of: ERP, HCM, CRM, and EMR. At the core of ITWR is a set of highly scalable, process-driven methodologies for recruiting experienced talent and driving talent, candidate, and client satisfaction. Awards: Best and Brightest, Inavero Best of Staffing (Client and Talent), No. 250 on the Inc. 5000, Inc. 5 in Atlanta, Pacesetter Award, and Best Companies to Work For. Looking for another position that will better suite your career objectives? I.T. Works Recruitment posts all of our open jobs on our website. Please visit www.itworksrec.com to view all open positions and apply for the right position for you. You can also call us a 678.291.0081 to speak with a recruiter today. I.T. Works Recruitment, Inc. is an Equal Opportunity Employer.