Job Description:
This position is a support role within the Analytical Method Sciences pillar, responsible for providing Analytical Method Configuration support in the Biologics Analytical Methods & Strategy group.
Duties and Responsibilities:
* Provide end-user support by troubleshooting Empower-related queries/questions or redirecting to the responsible group when needed.
* Create and maintain Empower by executing the appropriate change management process to support laboratory testing activities and ensure business, project, and/or investigation/CAPA timelines are met.
* Collaborate/liaise with 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.
* Author, revise, and/or review procedural documents, such as SOPs and Wis, and contribute to the development of associated training content.
* Communicate technical issues and activity status updates to team members/direct management.
* Maintain up-to-date knowledge on lab system functionality and apply it to improve system use and ensure an efficient user experience within the systems.
Qualifications:
* Bachelor's degree in a relevant scientific, computer, or engineering program.
* At least 1-3 years' experience in the biopharmaceutical industry or equivalent.
* BASIC knowledge and understanding of analytical techniques, including separations, compendial-based assays, and/or bioanalytical based methods.
* BASIC knowledge of databases and/or Microsoft Office Applications (Access, Excel, Project, PowerPoint, SharePoint, Teams, Word) and/or other relevant software programs, preferred.
* Ability to understand and follow cGMPs, regulatory requirements, and industry best practices.
* 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.
* Demonstrated problem-solving ability, attention to detail, and analytical thinking skills.
* Ability to provide ad-hoc support to users for issues/questions on Empower.
* Ability to work independently and as part of a team.
* Must be flexible to adjust workload to adapt to changing business needs.