Lab Systems Specialist
Position Summary
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.
Key Responsibilities:
Method Execution and Instrument Integration:
• Create, maintain and review master data/static data in current/future lab systems by executing the appropriate change management process to ensure accuracy of the configured analytical workflow 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/liase 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, intergration 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.
Qualifications & Experience
• Minimum B.S. degree in a relevant scientific, computer or engineering program area with at least 2 to 4 years’ 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.
