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Specialist Business Analyst, Biopharma LIMS - Remote (JP9561)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: Specialist Business Analyst, Biopharma LIMS - Remote (JP9561)
Location: Thousand Oaks, CA (Fully Remote) 

Employment Type: Contract
Business Unit: OIS Quality
Duration: Initial 3 months with likely extensions
Job posting date: 1/13/2022
Note: Remote

3 Key Consulting is hiring a Specialist Business Analyst -Remote for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:
  • The incumbent will be a results-oriented member of Quality OIS - Lab Systems client facing Information Systems team.
  • This role will serve as a Demand Owner to ensure requests for production system enhancements and fixes are prioritized and executed through the existing change control processes within the Product Monitor & Test service.
  • The incumbent will also be an occasional delegate of the Service Owner and will collaborate with development teams and external suppliers to deliver, operate, and continuously improve solutions in a manner that is scalable, secure, and aligns to approved methodologies.

  • Serve as an expert in LIMS functions supporting product release testing, stability, and environmental monitoring.
  • Lead requirements management, process design, and software implementation.
  • Actively engage business users to analyze business needs, elicit, refine, and document business and solution requirements and recommend design to meet efficiency, quality and client satisfaction goals and objectives.
  • Own the intake, assessment, and approval of enhancements for LIMS and LIMS reporting systems supporting GMP product release testing, stability and environmental monitoring.
  • Effectively engage business users to analyze business needs, elicit, refine and document business and solution requirements and recommend design to meet efficiency, quality and client satisfaction goals and objectives.
  • Lead vendors and contractors providing guidance as necessary to ensure the delivery of work
  • Ensure the incident and service requests are resolved within the Service Level Agreements (SLA)
  • Manage support vendors to ensure quality delivery of lifecycle management artifacts, including requirements, design, IQ, OQ and RTM.
  • Work with development team to help translate business requirements to technical specifications
  • Oversee all facets of testing (e.g. Unit Testing, Integration Testing, Functional Testing, System Testing, Usability Testing, Acceptance Testing, Regression Testing, Beta Testing)
  • Provide critical thinking and strategic discernment to resolve technical challenges
  • Work with and or adapt to multiple project methodologies (e.g. Agile, Rational, Waterfall).
  • Build and maintain productive working relationships with business clients.
  • Lead medium to large, cross-functional project teams/workstreams, facilitate meetings and present to management teams.
  • Conduct post-implementation assessment of projects to assure business requirements have been met.

  • Understanding of and ability to lead Agile teams (SCRUM)
  • Great teammate that can work with multi-functional teams, peer relationships, informing, understanding and appreciating differences.
  • Ability to follow to SOPs, methodologies and policies.
  • Experience working in a GMP regulated environment.
  • Self-starter with a high degree of initiative.
  • Highly motivated and able to work effectively under minimal supervision.
  • Excellent verbal, written, and interpersonal communication skills, including the ability to set the context and present on complex subjects in a clear and concise manner.
  • Experience in or C#, Oracle PL/SQL and Thermo VGL is a plus.

Top Must have Skill Sets:
  • 3-5 years’ experience as a Business Analyst supporting and implementing Thermo Fisher Lab Systems Sample Manager at a global scale.
  • Demonstrated understanding of requirements management and business processes design.
  • Working knowledge of laboratory information systems, lab execution systems and chromatography data systems.
Red Flags:
1. Prior Pharma/Biotech experience was as an end user rather than system support/Information Systems
2. Lack of clarity about prior work experience
3. lack of business analysis experience

Interview Process:
Video Conference with Panel 

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.

3KC Talent Acquisition Team
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