QC Data Specialist

Vor 2 Tagen

Boudry District, Schweiz Bristol Myers Squibb Vollzeit

Transforming Patients' Lives through Science

Bristol Myers Squibb is seeking a highly skilled QC Data Specialist to join our team in Boudry laboratory. As a key member of our laboratory team, you will be responsible for providing support in the development and maintenance of QC scheduling and planning systems to support drug product, drug substance, packaging items, PPQ and trial material testing on site.

This role requires partnering with QC network, system superusers, Information Technology teams, all levels of laboratory personnel and Laboratory sub-teams to ensure the process is designed and maintained for the laboratory personnel to meet testing requirements and commitments with operational efficiency in mind.

Key Responsibilities:

  • Develop, maintain, monitor and implement updates to data center tables (including new user setup)
  • Add new users to smart QC, indicating appropriate qualifications, work centers, shifts, etc.
  • Enter data for long-term and short-term forecasts.
  • Facilitates issue resolution (deep dives to understand why issues occur) and escalate as needed
  • Request and support for data updates in electronical systems.
  • Provide support for Laboratory personnel (Training, Incident management, ...)
  • Monitor interface between input systems (LIMS) and tool, including managing LIMS errors at the site.
  • Provide support for reporting capabilities: setup the correct reports going to the right level of leader in the organization at the right frequency.
  • Periodically verify data such at HOT times, campaign size, etc. which will impact planning and scheduling.
  • Periodically verify data such as time spent on unavailable tasks.
  • Provide data to leaders in the organization to identify opportunities for CI and/or to verify impact of CI initiatives.
  • Coordinate with LIMS team to ensure LIMS updates do not have unintended/unpredictable impacts
  • Maintain QC lab floor presence, ensuring that continuous feedback from all levels of the org is documented and that the scheduling and planning system reflects current practices.
  • Provide regular input to QC management regarding QC performance, and identify opportunities for improvements based on data.

Requirements:

  • Minimum B.S. degree in a relevant scientific, computer or engineering program area with at least 3+ years' experience.
  • Proficient knowledge of lab systems such as Smart QC, LIMS, ERP, etc., understanding of system management, data management, system interfaces and impact of changes to each other.
  • Proficient knowledge and understanding of Microsoft Office Applications (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 with experts.
  • Ability to troubleshoot issues identified and determine root 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.
  • Knowledge of analytical techniques.
  • Fluent in English and French, professional command of the second language (written and verbal).

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