Labware LIMS Specialist

Company: Alpha Consulting
Location: Phoenix
Posted on: November 26, 2022

Job Description:

*LABWARE LIMS SPECIALIST**PHOENIX, AZ**Project Description: ** This position is responsible for providing technical support in the development and maintenance of various QC lab systems user workflows to support various site manufacturing, stability, method transfer and non-routine testing activities to ensure compliance with procedures, methods, specifications, sampling plans, and data reporting requirements for raw material, water, microbial, biologics drug substance and/or biologics drug product testing.* This requires partnering with all levels of laboratory personnel, Information Technology, analytical support teams, and Quality Assurance to ensure processes are designed and maintained for lab systems to meet business and agency requirements with operational efficiency in mind.* Execute, create, or revise validation documents (i.e., UAT, URD, FRS, etc.) as applicable.* Support Business buildouts and LIMS changes .* Work with the site teams through the governance council to define release scope.* Support UAT execution in conjunction with validation efforts.* Works with the developer teams to verify that requirements are understood and delivered.* Design, review and/or execution of user acceptance testing (UAT) protocols.* Act as a Labware system Super User to support changes and end user process issues.* Provide first-line operations support to end users .* Provide first line coordination with Local IT/Tech support and system admins .* Assist with errors and solve problems with minimum guidance; perform simple data fixes.* Support site projects and goals where applicable to streamline testing.* Maintain and update master data objects .* Gathers documentation for the collection of Master Data using the LIST Template(s).* Standardizes and harmonizes master data per standards documented in the MD Configuration Standards SOP.* Work iteratively with the site SME's to develop consistent and accurate Master Data.* Reviews organized, standardized, and harmonized master data prior to build and provides verification of completed master data as needed.* Performs all activities in compliance to cGMP requirements and applicable standards and procedures.* Comply to EHS rules and safe work practices per applicable procedures.* Create and maintain local LIMS related standards and procedures .* Own or support change controls for LIMS changes .* Lead or support investigations in case of LIMS-related deviations .* Participate in inspections by health authorities and in corresponding preparation as LIMS SME.* Create and maintain master data/static data in lab systems by executing the appropriate change management process to support laboratory testing activities and to ensure business, project and/or investigation/CAPA timelines are met.* Support review of change controls associated with lab systems, identify system impact, and develop appropriate change actions required to support implementation of the change, including impact to interfacing systems.* Execute and document appropriate change control and/or verify changes executed by a team member are accurate associated within the lab system.* Review method/specification changes and work with appropriate SMEs to assess impact to lab systems data set up.* Execute standardization plan and contribute to identifying opportunities to standardize.* Test changes/enhancements through dry runs and receive feedback from lab users, when required.* Setup verification testing as appropriate for the lab system.* Execute User Acceptance Testing for system functionality changes.* Communicate impact of lab system changes to integrated systems areas (i.e., trending system, MES, etc.).* Collaborate/liaise with appropriate laboratory, manufacturing, analytical support and/or site/global IT teams to ensure needs and requirements are accurate in the lab systems.* Evaluate, recommend, and implement processes to improve compliance and the efficiency of laboratory testing operations (i.e., visibility to testing queues, testing metrics monitoring, etc.) to support product release, new products, and key performance indicators/lean lab metrics.* Contribute to the development/maintenance of processes for effective communication/visual dashboards for lab system work in progress and tracking team metrics.* Assist with compiling/tracking team metrics.* Author, revise, and/or review procedural documents, such as SOPs and WIs and contribute to the development of associated training content.* Assist with recruitment, integration, and training of less experienced staff on use of lab systems.* Train users on overview of system.* Provide ad hoc support to users for issues/questions on the lab system.* Communicate technical issues and activity status updates to team members/direct management.* Process user account requests for system access.* Maintain up to date knowledge on lab system functionality and apply functionality to improve system use and ensure efficient user experience within the systems.* Participate on/Lead teams in support of business process improvements/operational excellence.* Lead/Participate on small / medium project teams.* Develop Project Plans and Schedules and provide effective communications to customers and stakeholders.* Lead/Drive execution & visibility to status.* Resourcing and financial planning for small projects.* Assist with management of the day-to-day activities and prioritization of work, as business needs require.* Present information at group/department meetings.* Provide support for internal compliance and regulatory agency inspections as required.*Required Skills: ** Minimum B.S. degree in a relevant scientific, computer or engineering program area with at least 2 to 4 years' experience.* Laboratory Information Management System (LIMS) experience focus on Master Data Building - Labware highly preferred.* Good Manufacturing Practice (GMP) experience or other GxP experience.* Microbiology or Analytical Laboratory experience.* Advanced knowledge and in depth understanding of analytical techniques preferred.* Proficient knowledge of a lab system such as Empower, LES, LIMS, MODA, CIMS, etc., understanding of system interfaces and impact of changes to each other.* Proficient knowledge and understanding of Microsoft Office Applications (Access, Excel, Project, PowerPoint, SharePoint, Teams, Word) and/or other relevant software programs.* Demonstrated ability to work independently to complete assignments within defined time constraints.* Ability to execute changes in the lab system independently, proactively identify problems, troubleshoot issues, and develop potential solutions.* Respond to system issues and troubleshoot to identify cause.* Ability to interpret and apply cGMPs, regulatory requirements, and industry best practices.* Ability to exercise judgment and makes sound decisions within generally defined practices and policies to independently develop approach/solution.* Consult with technical if needed.* Demonstrated ability to effectively train and assist other less experienced individuals.* Ability to take initiative and prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility, independently or as part of a team.* Self-directed with a high degree of professional integrity, very organized, and detail oriented.* Demonstrated problem solving ability, attention to detail, and analytical thinking skills.* Strong interpersonal, oral, and written communication skills are essential.* Must contribute to a team based, collaborative and positive environment, clarity of purpose and high commitment to business goals.* Ability to work on multiple complex projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations.* This position may require -10% travel.This 12+ month position starts ASAP.ALPHA'S REQUIREMENT #22-03096MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEEJob Types: Full-time, ContractBenefits:* 401(k)* Dental insurance* Health insurance* Health savings account* Referral program* Vision insuranceSchedule:* 8 hour shift* Weekend availabilityWork Location: One location

Keywords: Alpha Consulting, Phoenix , Labware LIMS Specialist, Other , Phoenix, Arizona