Job#: 3056660 Job Description: Role: Business Quality Analyst - LabVantageDuration: 10+ month Contract Location: Remote Apex Systems, a Global Life Sciences Consulting Organization, is seeking an experienced Business Quality Analyst to support a global LabVantage LIMS upgrade within a highly regulated pharmaceutical environment. This role will focus on LabVantage 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 LabVantage 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 LabVantage environment meets business needs and applicable quality requirements.
Key Responsibilities- Provide Business Quality and QA oversight for the LabVantage 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 LabVantage workflows and functionality.
- Participate in gap assessments between the current and upgraded LabVantage 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 LabVantage LIMS in a pharmaceutical, biotechnology, or other regulated laboratory environment.
- LIMS migration experience, preferably in LabVantage
- 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 skills with the ability to identify and escalate project or quality barriers.
- A bachelor's degree in a scientific or technology related field
Preferred Qualifications- Experience supporting large-scale or global LIMS environments.
- Familiarity with FDA 21 CFR Part 11, EU Annex 11, ALCOA+ data integrity principles, and related pharmaceutical computerized-system expectations.
- Experience with laboratory data migration, master data verification, and system regression testing.
- Experience supporting QC laboratory operations and understanding how LIMS platforms support testing and laboratory workflows.
- Experience working with cross-functional or global pharmaceutical teams.
Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.
Everforth Apex uses a virtual recruiter as part of the application process. Click for more details. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Everforth Apex and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at
Everforth Apex Benefits Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Everforth Apex team member can provide.
Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.
If you require an accommodation under the Americans with Disabilities Act to participate in an interview with a virtual recruiter or to use our website for a search or application, please contact our Benefits Department at or . Please note that this contact information is strictly to be used for medical ADA accommodations and that no other inquiries will be answered.
UnitedHealthcare creates and publishes the Transparency in Coverage Machine-Readable Files on behalf of Everforth Apex Systems.
