Principal Business Systems Analyst - Quality Control

Regeneron Pharmaceuticals, Inc
RENSS
Full-time

We are looking to hire a Principal Business Systems Analyst for our Quality Control team. This position is a Monday - Friday, 8am-4 : 30pm schedule.

This QC transformational role leads a technical team in configuration, implementation, deployment and support of new and existing QC IT applications (LIMS, ELN, SDMS, Empower, Data Warehouse).

Drives the coordination and translation of QC IT needs and requirements into transformational ground breaking IT solutions.

As a Principal Business Systems Analyst, a typical day might include the following :

  • Analyzes business needs to resolve technical requirements and identifies impacted areas / systems / processes and evaluates solutions.
  • Partners with developers, vendors and IT BRMs to ensure the design fulfills business and technical requirements.
  • Serves as QC Owner of LIMS and other GxP systems - approving / processing change controls and account change requests.
  • Leads team which provides administrative support for additional computerized systems such as : LIMS, ELN, SDMS, Empower, Data Warehouse, SharePoint and other laboratory software.
  • Designs, develops, documents, tests or supports modification of computer programs and / or systems.
  • Continuously assesses systems as business direction changes for impacts to existing designs; understands impacts and works as appropriate to resolve best solution.
  • Reviews and approves documents and ensures consistency with SOPs and current formats.
  • Works with cross-functional teams to plan and drive QC IT projects and initiatives.
  • Coordinates the needs of QC functional areas and establishes priorities for LIMS configurations, such as implementation of new specifications, design of LIMS templates for new / revised test methods, design of queries and reports
  • Escalates issues, such as priority conflicts or project timeline delays, to QC management.
  • Works with the IT group on projects such as defining User Requirement Specifications and execution of test plans.
  • Writes and revises Standard Operating Procedures (SOPs), User Requirement Specifications (URSs) and Functional Requirement Specifications (FRSs) with current formats.
  • Participates in interviewing, hiring, training, coaching and disciplinary actions.

This role might be for you if you have :

  • Strong working knowledge of laboratory IT Systems such as LIMS, ELN, SDMS and / or Empower.
  • The ability to manage multiple, complex projects and changing priorities and work effectively in a team environment.
  • The ability to motivate and lead a team; supervising and coaching staff.
  • Strong team leadership skills, attention to detail and organizational skills.
  • Excellent written, verbal and interpersonal communication skills and the ability

to effectively interact with all levels.

  • Organizational and time management skills.
  • A positive, proactive approach to drive projects / tasks to completion.
  • Familiarity with electronic lab management systems, quality compliance requirements and data integrity.

To be considered for a Principal Business Systems Analyst position you must be willing and able to work Monday - Friday, 8am-4 : 30pm.

This position requires a BS / BA in a related field and 8 years of relevant laboratory and / or database / LIMS experience or equivalent combination of education and experience.

Strong working knowledge of laboratory IT Systems such as LIMS, ELN, SDMS and / or Empower is required.

30+ days ago
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