27 Jan
Empower Lab Systems Specialist
Massachusetts, Devens , 01434 Devens USA

Vacancy expired!

EMPOWER LAB SYSTEMS SPECIALISTDEVENS, MA - REMOTE 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-routing 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. This position will be primarily involved with support of Empower and Electronic Laboratory Notebook (ELN) configurations and user support.Major Duties and Responsibilities:

  • Primary responsibilities for this role will be the creation and modification of Empower Methods, Custom Fields, and Reports within a GMP environment.
  • Experience with additional laboratory data systems such as ELN and/or LIMS is also preferred.
  • Familiarity with a diverse range of chromatographic based methods and techniques is desirable.
  • Candidates must be able to independently perform and document laboratory data system changes in accordance with Good Documentation Practices and the governing Test Methods and Standard Operating Procedures.
  • 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.
  • 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.
  • 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.
  • Provide support for internal compliance and regulatory agency inspections as required.
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 chromatographic techniques preferred.
  • Proficiency using and configuring Empower Methods, Custom Fields, and Reports is required.
  • Additional experience with laboratory software such as LES, LIMS, MODA, CIMS, etc. and understanding of system interfaces and impact of changes to each other are desired.
  • Proficient/Advanced 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 exercises judgment and makes sound decisions within broadly defined practices and policies. Apply appropriate notification to management as appropriate.
  • 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.
This 6+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Briana: ALPHA'S REQUIREMENT #21-00259MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE #ZR

Vacancy expired!


Report job