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Business Systems Analyst, Analytical Laboratory Systems - Pharma

Foster City, CA · Biotech/Pharmaceutical
Title: Business Analyst, Analytical Laboratory Systems - Pharma
Location: Foster City, CA
Type: Contract - 12-24+ months

Our direct client is looking for a Business Systems Analyst with an analytical laboratory background, who is proficient in both lab business processes and has experience running lab instrumentation and systems

Job Details:
  • Must have laboratory background, very knowledgeable of laboratory business process, has hands-on experience with laboratory instrumentation (pH meter, KF, Balance, UV, LC etc) and systems.
  • Implement laboratory processes and analytical testing with Lab systems such as LabX, LIMS, ELN, LES and Empower.
  • Conduct business analysis: Review/assess current business process for various laboratory testing using lab instruments. Identify gaps/opportunity to improve. Map ‘To-be’ process after discussion with system and business teams.
  • Develop deliverables: Visio maps, use cases, UAT (User Acceptance Testing), user manuals, requirements document such as BRD (Business Requirement Document)/URS (User Requirement Document)
  • Run Instrumentation: As part of business analysis, person will be required to run laboratory instrumentation before conducting user sessions for feedback.
  • Conduct sessions such as workshops, brainstorming, walkthrough, UATs, and meetings to discuss current and To-Be processes.
  • Support: computer systems validation and related documentation and activities and user training.
Skills required:
  • Hands on experience on laboratory instrumentation
  • Knowledge of laboratory systems (LIMS, ELN, LES, LabX, and Empower) and laboratory processes such as Stability study/reference standards/Method validation
  • Well versed in software tools like MS Office (Work, Powerpoint, excel, Visio, Project), MS Teams
  • Have understanding about FDA regulations for laboratory testing at minimum Instrument Qual, CSV, Data Integrity
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