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.
Manager, Laboratory Informatics Management Systems
ROLE AND RESPONSIBILITIES:
Reporting to the Technical Lab Director – Regulatory Chemistry. The candidate will support the Chemistry and Regulatory Testing and regulatory submission for JUUL Labs. This position will be located on site in Durham, NC laboratory.
- Support our Laboratory Information Management (LIMs) system including the configuration, customization, integrity, and on-going support of all functional user groups.
Manager, Laboratory Informatics Management Systems
ROLE AND RESPONSIBILITIES:
Reporting to the Technical Lab Director – Regulatory Chemistry. The candidate will support the Chemistry and Regulatory Testing and regulatory submission for JUUL Labs. This position will be located on site in Durham, NC laboratory.
- Support our Laboratory Information Management (LIMs) system including the configuration, customization, integrity, and on-going support of all functional user groups.
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