Sr Consultant – GMP/ OneTrust Support
Minimum Qualification:
In the Field of GMP/Analytics
- 5 years practical experience on Google Marketing Platform Technologies
- Strong experience with Google Analytics/Google Analytics 360
- Good knowledge of reporting in Google Analytics as well as linking tools, creating Segments and creating Properties, Views and Filters
- Strong experience with Google Tag Manager
- Partner with IT development teams for user acceptance testing and implementation
- Diagnose/Debug issues with existing platform configurations and tags, and provide recommendations for improvement
- Work with third parties to resolve discrepancies or platform issues with GMP/GTM
- Experience with client-side web technologies, HTML, CSS, JavaScript and jQuery
- GA4 knowledge and implementation experience is a plus
In the Field of OneTrust
- Maintaining the integrity of data and processes in OneTrust
- Supporting the team with OneTrust assessments
- String experience using OneTrust for Cookie compliance, including scanning and banner implementation
- OneTrust Cooke compliance integration with Google Tag Manager
LIMS/Empower Support
- Administration and support of the Empower environment.
- Manage and resolve Tier 3 & 4 Empower issues.
- Manage on-boarding, retirement, and relocation of equipment.
- Proactively monitor the environment.
- Manage the installation and configuration of Empower 3 LAC/e computers in client laboratory space.
- Follow GmP and GxP best practices.
LIMS Project Manager
Qualifications
- 8+ years of Project Management or Program Management experience
- Experience working in the pharmaceutical industry
- Experience with Laboratory Information Management System (LIMS)
- Knowledge of 21 CFR Part 11
- Experience in a GxP FDA regulated environment
- Managing cross-functional project teams
- Experience in project governance – maintaining and updating project artifacts
- Experience implementing CMMS systems is a big plus
- Bachelor’s degree or equivalent
Responsibilities
- The Project Manager – Laboratory Information Management System (LIMS) develops and implements detailed project plans, including new products, conversion/integration, merger projects, and other projects as assigned
- The Project Manager – LIMS also manages the planning, documenting, testing, and executing, along with tasks, budgets, and timelines to successfully complete projects on time and within budget
- In addition, he/she develops documentation to support the project planning and implementation process
- Follow Project Management methodology and create relevant artifacts for project
- Work closely with software vendor and professional services and internal team members including business stakeholders
- Direct the due diligence information gathering, analysis, and reporting
- Support business process changes to meet project goals
- Advise on milestones as needed for reporting to appropriate management levels and communicates budget and status milestones as defined for the project
Senior Labware LIMS CSV engineer with GMP
Responsibilities
- Develop Validation Plans and Change Controls for Labware LIMS (Laboratory Information Management System)
- Develop Validation testing strategy in accordance with company's policy and procedures
- Working closely with System Manager, Quality Assurance and Business Process Owners to effectively and efficiently implement LIMS projects
- Assist with understanding the business requirements, analyze and suggest technical solution for LIMS projects
- Work closely with other validation team members to ensure system impact is assessed and mitigation strategy is in place for multiple sites using LIMS application
- Create, review & approve CSV deliverables such as, User/Functional Specification, Design specification, IQ/OQ/PQ qualifications for LIMS projects
- Qualification protocols execution and final report view and approval for LIMS projects
- Partner closely with the business to ensure that CSV methodologies are well understood and applied in a manner that will procedure the most value on LIMS projects
- Learn and become proficient with the EDMS (Electronic Data Management System), for
- document review and approval and ELMS (Electronic Learning Management System) for documenting and performing assigned training.
LIS v. LIMS – What’s the difference between the systems?
If you’re shopping for laboratory software, you’ve probably come across these two software systems a few times – LIS and LIMS. In healthcare laboratory informatics, LIS and LIMS systems are frequently mentioned together, leading some to assume they are the same thing.
[Read More]
Unrealized Expectations: A Realistic View on LIMS Implementations
Congratulations on your decision to purchase a new laboratory information management system (LIMS) or upgrade your current platform! Once the ink has dried on the contract you might start to wonder, what’s next? [Read More]
Solving the Unsolvable: Enabling the Fully Connected Digital Lab
The digital lab concept has been around for decades, with nearly every science-based organization seeking ways to achieve complete digitalization and automation throughout their operations. Progress has been made in many areas, however, the full power and benefits have yet to be realized... [Read More]
Laboratory Informatics Weekly Update – Volume 20, Issue 5
February 2, 2022 Laboratory Informatics Weekly Update Volume 20, Issue 5 In This Issue Featured Books Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research Featured Content 02/02/2022 - LIS v. LIMS – What’s the difference between the systems?If you’re shopping for laboratory software, you’ve probably come across these two software systems a few times – LIS and LIMS. In healthcare laboratory informatics, LIS and LIMS systems are frequently mentioned together, leading some to assume they are the same thing. [Read More] 02/02/2022 - Unrealized Expectations: A Realistic View on LIMS ImplementationsCongratulations on your decision to purchase a new laboratory…A survival guide for the rapid transition to a fully digital workflow: The Caltagirone example
Back in December we posted an article by Fraggetta et al. on recommended best practices when implementing a digital pathology workflow. However, a month before that article was published in the journal Diagnostics, Fragetta and a different group of authors published a paper on digital pathology implementation, from the perspective of implementing it in the Gravina Hospital system in Sicily. This paper examines the hospital's transition step by step, demonstrating "the digital transition of analog, non-tracked pathology laboratories" to an improved digital workflow. After describing the hospital's prior situation and explaining their methods, the authors discuss the results of their implementation in detail, from initial accessioning to final archiving. After a lengthy discussion, the authors conclude that "following the step-by-step instructions, the implementation of a paperless routine with more standardized and safe processes, the possibility to manage the priority of the cases and to implement AI-based tools is no more a utopia for every analog pathology department."
