The Planet Group
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http://www.theplanetgroup.com
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LIMS LabVantage Business Analyst
8810 Rehco Road San Diego, CA 92121 US
Posted: 02/15/2024
2024-02-15
2024-03-16
Employment Type:
Direct Hire/Perm
Job Category: LIMS
Job Number: 612353
Country: United States
Is job remote?: No
Job Description
LIMS LabVantage Business Analyst – (Full-time) – Hybrid – southern CA
Pharmaceutical Manufacturer seeks a LIMS LabVantage Business Analyst, for a full-time hybrid opportunity in southern California. 5+ years’ experience as LIMS LabVantage Business Analyst, with one full SDLC LIMS Implementation required. Validation, Project Management and GMP environment expertise are also a requirement. Primary responsibilities include driving requirements gathering and authoring these along with additional documentation (workflows, SOPs, Validation Plans, etc.), while serving as point-of-contact with LIMS vendor to provide user solutions and rolling these out, ensuring thorough understanding and utilization from user. This requires onsite for requirements gathering and then can become more hybrid, with some east coast travel. Opportunity offers extremely competitive base compensation and benefits, as well as exposure to a full SDLC paper to electronic LIMS implementation. US Citizen or Green Card work authorization is required with individual willing to be onsite as needed.
Requirements:
Responsibilities:
Benefits:
Pharmaceutical Manufacturer seeks a LIMS LabVantage Business Analyst, for a full-time hybrid opportunity in southern California. 5+ years’ experience as LIMS LabVantage Business Analyst, with one full SDLC LIMS Implementation required. Validation, Project Management and GMP environment expertise are also a requirement. Primary responsibilities include driving requirements gathering and authoring these along with additional documentation (workflows, SOPs, Validation Plans, etc.), while serving as point-of-contact with LIMS vendor to provide user solutions and rolling these out, ensuring thorough understanding and utilization from user. This requires onsite for requirements gathering and then can become more hybrid, with some east coast travel. Opportunity offers extremely competitive base compensation and benefits, as well as exposure to a full SDLC paper to electronic LIMS implementation. US Citizen or Green Card work authorization is required with individual willing to be onsite as needed.
Requirements:
- US Citizenship or Green Card work authorization; located in the states.
- Bachelor’s Degree in the Sciences or a related area.
- 5+ years as a Business Analyst and with LabVantage LIMS.
- 1+ full SDLC LabVantage LIMS implementation.
- GMP regulated environment experience.
- Project Management and Validation experience required, with a PMP desired.
- LIMS module experience in Sample Management and Environmental Monitoring.
- Prior exposure to LabVantage Cloud is idyllic as well as AWS.
- Calibration and preventative lab instrumentation is desired but not required.
- Personable and can-do attitude with a highly detail-oriented approach.
- Ability to be onsite as needed in southern California, and for east coast travel up to 25% of the time during requirements as needed.
- Desire to manage a team down the line.
Responsibilities:
- Serving as sole internal Business Analyst on LIMS implementation from paper to electronic, and for instrumentation integrations.
- Mapping workflows and requirements for sample management and environmental monitoring to include extensive documentation authoring, editing and rollout.
- Mapping instrumentation workflows within a GMP environment to develop required remediation for completion prior to LIMS integration.
- Liaising with vendors and end users as LIMS Business Analyst.
- Performing vendor negotiations to ensure best cost is secured, appropriate products and services are utilized according to organizational needs, and validation costs are determined, ideally optimizing the budget effectively.
- Regularly making recommendation for LIMS and instrumentation utilization based on organizational needs and budget.
- Serve as in-house SME for all levels of users, with the capacity to speak to each user based upon their level of knowledge.
- Develop support plan for LIMS throughout post implementation phase hypercare for long-term support and maintenance.
- Assisting in system validation to include GxP CFR Part11.
- Performing project management as needed for new projects.
Benefits:
- Competitive base compensation depending upon the individual and experience level.
- Annual Bonus up to 20% based on organizational/individual performance.
- 401K with up to a 4% company match, at 100%.
- Full Health, Dental and Vision Benefits.
- 23 days PTO an increase after 5 years employment to 28 days.
- 7 holidays.
- Relocation offered based on individual location and requirements.
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