QC Systems Analyst II
South San Francisco, California
28d ago
  • Create, revise, and review LIMS master data for IMP products.
  • Provide maintenance and support for master data as required.
  • Participate on interdepartmental / global teams, process improvements, or new system design.
  • Ensure the smooth introduction of new, routine, and complex master data functionality of the software as they are added.
  • Act as subject matter expert (SME) by demonstrating master data and software proficiency.
  • Develop and maintain expert working knowledge of LIMS functionality through all software upgrades and project implementations.
  • Provide technical expertise for LabWare LIMS projects, troubleshooting of system, and interfacing of data.
  • Initiate or assess discrepancies associated with master data issues.
  • Make informed decisions on master data issues in collaboration with key stakeholders and adhering to system requirements.
  • Possess analytical and / or computer skills sufficient to : 1) Understand data requirements and interdependencies, 2) Solve problems through effective trouble shooting and suggest viable solutions, 3) Continuously improve systems achieving increased compliance and efficiencies.
  • Translate business needs into user requirements for complex master data enhancements.
  • Support IMP reference standard expiry extensions, including generation of trend charts and reports.
  • Review and respond to problems, monitor issues and initiate resolutions.
  • Accomplish corporate, operational, and departmental goals.
  • Work with internal departments and outside vendors, collaborators and partners concerning projects and commitments.
  • Be flexible and adapt to changing work priorities, as needed.
  • Maintain an inspection-ready state, and support GMP audits.
  • Collaborate with management to establish and meet targets and timelines.
  • At least 3-5 years of relevant experience in Quality Control, Quality Assurance or equivalent experience in the pharmaceutical / biotechnology industry.
  • Experience with data management, in particular working knowledge of LIMS systems.
  • Good understanding of GMP principles and regulations.
  • Flexibility in problem solving to meet business objective.
  • Ability to make sound decisions regarding scheduling and managing priorities.
  • Ability to communicate clearly and professionally both in writing and verbally.
  • Demonstrate interpersonal skills to work effectively with internal stakeholders, customers, contractors, and cross-functional project teams.
  • Education : BS degree in Life Science or equivalent.

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