Posted: 10/03/20242024-10-032024-11-04Employment Type:ContractJob Category:LIMSJob Number: 622577Is job remote?: NoCountry: United States
Job Description
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 (IQ, OQ and PQ scripting) 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 specifically with regard to instrumentation flow, integrations and interfacing.
Working directly with vendors on SDMS, LIMS and instrument configurations.
Assisting with instrumentation and workstation interfacing including LIMS (Watson), SDMS (NuGenesis), and Instrumentation (Water’s).
Collaborating with cross functional stakeholders to perform Proof of Concept testing.
Developing, reviewing, and obtaining approval of full SDLC documentation.
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.
Performing testing while ensuring system meets business needs; resolving defects.
Implementing business configurations and administering as needed.
Developing test cases for systems and software to include both Watson LIMS and NuGenesis SDMS.
Performing Validation as needed to include writing IQs, OQs, and PQs.
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.
2+ years working with laboratory analysts as BA to perform end-to-end business process testing between instrumentation, SDMS, and Downstream systems.
2+ years performing system validation to include writing IQs, OQs, and PQs.
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.
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Planet Technology and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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