Senior Specialist, Quality Assurance Technical Operations - TechDigital
Devens, MA
About the Job
Job Description:
Major Duties and Responsibilities
• Create and maintain master data/static data in SampleManager LIMS (SMLIMS) by executing the appropriate change management process to support laboratory testing activities and to ensure business, project and/or investigation/CAPA timelines are met.
• Test changes/enhancements through dry runs and receive feedback from lab users, when required.
• Execute User Acceptance Testing for system functionality changes.
• Communicate impact of SMLIMS 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 SMLIMS.
• 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.
• Provide ad hoc support to users for issues/questions on SMLIMS
• Communicate technical issues and activity status updates to team members/direct management.
• Maintain up to date knowledge on lab system functionality and apply functionality to improve system use and ensure efficient user experience within SMLIMS.
• Participate on teams in support of business process improvements/operational excellence.
• Participate on small / medium project teams.
Required Knowledge/Skills/Qualifications
Education:
Minimum B.S. degree in a relevant scientific, computer or engineering program area with at least 2 to 4 years' experience.
Experience/Knowledge:
• Advanced knowledge and in depth understanding of analytical techniques preferred.
• Proficient knowledge of a LIMS system, preferably SampleManager LIMS.
• 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 lead if needed.
• Demonstrated ability to effectively train and assist other less experienced individuals
Skills/Competencies:
• 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.
Major Duties and Responsibilities
• Create and maintain master data/static data in SampleManager LIMS (SMLIMS) by executing the appropriate change management process to support laboratory testing activities and to ensure business, project and/or investigation/CAPA timelines are met.
• Test changes/enhancements through dry runs and receive feedback from lab users, when required.
• Execute User Acceptance Testing for system functionality changes.
• Communicate impact of SMLIMS 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 SMLIMS.
• 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.
• Provide ad hoc support to users for issues/questions on SMLIMS
• Communicate technical issues and activity status updates to team members/direct management.
• Maintain up to date knowledge on lab system functionality and apply functionality to improve system use and ensure efficient user experience within SMLIMS.
• Participate on teams in support of business process improvements/operational excellence.
• Participate on small / medium project teams.
Required Knowledge/Skills/Qualifications
Education:
Minimum B.S. degree in a relevant scientific, computer or engineering program area with at least 2 to 4 years' experience.
Experience/Knowledge:
• Advanced knowledge and in depth understanding of analytical techniques preferred.
• Proficient knowledge of a LIMS system, preferably SampleManager LIMS.
• 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 lead if needed.
• Demonstrated ability to effectively train and assist other less experienced individuals
Skills/Competencies:
• 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.
Source : TechDigital