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LIMS/QMS Business Analyst

Pasadena, CA 91104

Posted: 05/19/2023 Employment Type: Direct Hire/Perm Job Category: LIMS Job Number: 539953 Is job remote?: Yes Country: United States

Job Description

LIMS or QMS Business Analyst - (Full-time) – Hybrid – Northeast Los Angeles – CA
Privately held Biotech Research Organization seeks a hybrid local LIMS or QMS Business Analyst to join the LIMS team to  assist in all end-to-end documentation for a highly customized Labware v6 LIMS that will likely be upgraded to Labware v8. The ideal candidate will work with users to gather requirements to include the creation of SRS, URS, and validation documentation. Additionally, the individual will ensure all business analysis is performed efficiently throughout the entire SDLC process to include validation. Opportunity will provide ideal candidate exposure to various projects to include Stability, Standards and Reagents modular implementations. Additionally, strong compensation and benefits are provided within a truly team-oriented environment, with the likelihood of being a part of a new LIMS LabWare upgrade to the latest version 8.

Benefits:
  • Competitive salary commensurate with individual experience.
  • Up to 100% medical, dental and vision insurance provided for employees and their families beginning on the first day of employment.
  • 401K company match
  • Performance-based discretionary bonuses and annual merit increases
  • 4-weeks PTO accrued within the first year
  • Work/Life balance to include generous time off program for new parents, flexible work schedules, and company sponsored social events.
  • Highly collaborative environment with an open culture and within a high growth phase.
  • A team-oriented environment to mentor and be mentored as desired.
  • Company stock options.

Responsibilities:
  • Working with users to gather requirements to include Software Requirements Specifications (SRS), User Requirements Specifications (URS) and validation documentation.  
  • Performing systems testing regularly.
  • Understanding the full SDLC to include system validation, with the ability to perform this.
  • Working with LabWare SMEs and users to perform analysis while ensuring the utmost system functionality, and in preparation of upgrade.
  • Performing business analysis to include documenting of end-to-end processes including requirements design, testing (test plans, test cases and test scripts), Process Flow Charts, User Stories, FRS, Summary Reports, Training Manuals and more.
  • Leading communications between business and technology teams, in addition to some small projects independently.
  • Ensuring all backlogs are updated and prioritized regularly to resolve issues in a timely manner and adhere to organizational SOPS and Change Control Procedures.
  • Regularly running daily, weekly, and monthly agile rituals while collaborating with internal teams to obtain an in-depth understanding of systems and business processes, while documenting accordingly.
  • Recommending relevant user requests; evaluating information gathered and reconciling conflicts to ensure requests are escalated accordingly, based upon importance.
  • Documenting current as-is processes in collaboration with SMEs to design desired processes, while performing gap analysis and recommending proper business process improvements.
  • Translating software functions and features into process-driven user-friendly materials that support the implementation and training for a variety of applications.
  • Reviewing and defining project requirements to ensure they are in alignment with business objectives.

Requirements:
  • Bachelors in computer science, or related area.
  • US Citizen or Green Card Holder.
  • Covid Vaccination.
  • 4+ years of proven experience in technical writing of software documentation, work within an FDA or Biologic environment.
  • Experience in providing production support for enterprise systems (triaging closing tickets while producing change control documentation).
  • Knowledge of Agile approaches – Kanban, Scrum.
  • Proven history in providing production support for enterprise systems.
  • Understanding of full SDLC and validation concepts having produced documentation for validated systems.
  • Ability to make complex concepts easily understandable using text and visual aids.
  • Strong knowledge of Microsoft Office including Visio.
  • Excellent communication skills required.
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