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
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.
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