Lab Systems R&D Business Analyst w/SDMS – (Contract) – Hybrid – CA
Global Biotech organization seeks a Lab Systems R&D Business Analyst with SDMS for a year+ contract hybrid opportunity with 3 days onsite north of San Francisco, CA. Ideal candidate will have a background working within a laboratory, and 2+ years’ experience implementing lab systems to include LIMS and SDMS, as well as validation within a regulated environment. Individual must be a strong Business Analysis with a history of performing requirements gathering, process mapping (specific to SDMS, Lab instrumentation and processes) and strong documentation expertise (SOPS, Data/Process Flows, SDLC deliverables – URS, FRS, Configuration Specs, Test Scripts, etc.). The R&D Business Analyst will work to implement instrumentation systems and software requirements to meet business needs. Data management and writing test scripts are also required. Opportunity affords ideal candidate a long-term contract with potential extensions and exposure within a global organization and project.
Responsibilities
- Partnering with laboratory users and business experts to ensure software requirements are met and utilized.
- Authoring and editing SOPs, work instructions, training materials, Data/Process Flows, SDLC deliverables – URS, FRS, Configuration Specs, Test Scripts, and more.
- Analyzing, developing, and documenting lab data workflows and process mapping.
- Collaborating with cross functional stakeholders to perform Proof of Concept testing.
- Developing, reviewing, and obtaining approval of full SDLC documentation.
- Working directly with vendors on SDMS, LIMS and instrument configurations.
- Providing post go-live support for a variety of users and systems as needed; while also rolling out solutions and training on system functionality accordingly.
- Assisting with instrumentation and workstation interfacing including LIMS (Watson), SDMS (NuGenesis), and Instrumentation (Water’s).
- Performing testing while ensuring system meets business needs; resolving defects.
- Regular utilization and optimization of LIMS and SDLC.
- Implementing business configurations and administering as needed.
- Developing test cases for systems and software to include both Watson LIMS and NuGenesis SDMS.
Requirements
- Ability to work onsite within a hybrid role, 3-days per week just north of the Bay area.
- Prior SDMS and LIMS expertise as business analyst, with a preference for NuGenesis.
- Prior instrumentation integration expertise as business analyst, Water’s preferred.
- Prior experience working with laboratory analysts as BA to perform end-to-end business process testing between instrumentation, SDMS, and Downstream systems.
- A history authoring and editing SOPs, work instructions, training materials, Data/Process Flows, SDLC deliverables – URS, FRS, Configuration Specs, Test Scripts, and more.
- A history of working within the laboratory having experience initiating and management Change Control and Deviation requests.
- Expertise in data integrity and management to include data workflows and processes within regulated R&D environment.
- Be located in San Francisco Bay area or north of, to work onsite within a hybrid role.
Benefits
- Afford W2 or 1099 Candidate ability to work within a long-term contract for a global organization.
- For W2 consultants, the option for health, vision, and dental benefits.
- A hybrid opportunity with 2-day work-from-home schedule
- Exposure to cutting edge systems to include Waters Instrumentation, SDMS NuGenesis, and Watson LIMS.
