Lab Systems Business Analyst
Type of role: Contract 12+ Months
Location: Foster City, CA 94404
***Must be local in order to go in to work on-site occasionally
Our direct client is looking for a Business Analyst for pharmaceutical laboratory systems and processes. This individual must have a laboratory background, be very knowledgeable of laboratory business process, and have hands-on experience with laboratory instrumentation (pH meter, KF, Balance, UV, LC etc) and systems. This person will be key to streamline business processes which are established through various systems like LIMS, ELN, LES, LabX etc for different analytical testing.
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 about 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 (Word, Powerpoint, excel, Visio, Project), MS Teams
- Have understanding about FDA regulations for laboratory testing at minimum Instrument Qual, CSV, Data Integrity