Business Quality Analyst- LabVantage

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Job Description # Business Quality Analyst
- Lab Vantage Apply
** Job#: 3056660
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* Job Description:

**** Role:
Business Quality Analyst – Lab Vantage
**** Duration: 10+ month Contract
***
* Location:

Remote
** Apex Systems, a Global Life Sciences Consulting Organization, is seeking an experienced Business Quality Analyst to support a global Lab Vantage LIMS upgrade within a highly regulated pharmaceutical environment. This role will focus on Lab Vantage System Quality and the quality and validation activities required to successfully implement the upgraded platform.

This is not a Method Management or SOP-focused QA position. The primary focus is the Lab Vantage platform, computer system validation, system testing, data integrity, and GxP compliance.

The Business Quality Analyst will work across Quality, QC Laboratories, business stakeholders, validation teams, and IT to ensure the upgraded Lab Vantage environment meets business needs and applicable quality requirements.
** Key Responsibilities
*** Provide Business Quality and QA oversight for the Lab Vantage LIMS upgrade
* Partner with QC laboratories, Quality, IT, validation resources, and business stakeholders throughout the system upgrade.
* Review business and user requirements and help determine their impact on existing Lab Vantage workflows and functionality.
* Participate in gap assessments between the current and upgraded Lab Vantage environments.
* Review and support validation documentation, including user and functional requirements, test scripts, and requirements traceability.
* Support User Acceptance Testing (UAT) and other system testing activities.
* Understand IQ/OQ/PQ and computer system validation activities as applicable to the upgrade.
* Review testing results and confirm that identified issues are appropriately documented and resolved.
* Identify, document, and help triage system defects, deviations, and quality issues identified during testing.
* Partner with technical teams to track defects through resolution and retesting.
* Support data migration and verification activities to ensure data remains accurate and complete through the upgrade.
* Evaluate system changes from a GxP, data integrity, and business quality perspective.
* Support system change control and quality documentation associated with implementation and release.
* Ensure the upgrade maintains appropriate controls for regulated electronic records, audit trails, system access, and electronic signatures.
* Communicate risks, quality concerns, testing issues, and project barriers to appropriate project stakeholders.
* Support document and training updates when system changes affect established business processes.
** Required Qualifications
*** Experience working with Lab Vantage LIMS in a pharmaceutical, biotechnology, or other regulated laboratory environment.
* LIMS migration experience, preferably in Lab Vantage
* Hands-on experience supporting LIMS implementations, upgrades, releases, or major system changes.
* Experience providing Business Quality, QA, CSV, validation, or quality-system support for regulated computerized systems.
* Working knowledge of GxP requirements and data integrity expectations within a pharmaceutical environment.
* Experience with computer system validation and the system development/validation lifecycle.
* Experience reviewing or developing requirements, validation documentation, test scripts, UAT documentation, and traceability.
* Understanding of IQ, OQ, and PQ concepts within validated computerized systems.
* Experience supporting deviation, defect, issue, and change control processes associated with validated systems.
* Ability to work across QA, QC laboratories, IT, validation, and business teams.
* Excellent written and verbal communication…