Blue Marble Analytics · 2 days ago
Senior Quality Assurance Specialist
Indianapolis, IN
Full-time
Hybrid
Senior Level
5+ years expBlue Marble Analytics is a pioneer in delivering strategic IT and data-based solutions that allow organizations to maximize value from their people and their data. The Quality Assurance (QA) Specialist supports Computer System Validation (CSV) and Quality Assurance activities for GxP-regulated systems in the life sciences domain, ensuring that computerized systems are compliant and audit-ready.
Management Consulting
Responsibilities
Support the development, review, and maintenance of validation documentation including, user requirements specifications (URS), functional requirements rpecifications (FRS), risk assessments, IQ/OQ/PQ protocols and test scripts, validation summary reports (VSR)
Assist with execution of validation testing and documentation of test evidence under supervision
Support risk-based validation activities aligned with GAMP 5 principles
Support 21 CFR Part 11 and Annex 11 assessments for electronic records and electronic signatures
Help ensure documentation meets internal SOPs and regulatory expectations
Assist in maintaining systems in a validated state by supporting, periodic reviews, change control documentation, deviation and CAPA documentation
Organize and maintain validation and quality documentation for audit readiness
Support internal audits and inspection preparation activities
Assist senior QA staff during regulatory inspections by gathering evidence and responding to requests
Work with IT, quality, manufacturing, and business stakeholders to support validation timelines
Participate in project meetings and document action items and follow-ups
Support system implementation, upgrades, and enhancements under senior oversight
Qualification
Required
Bachelor's degree in Life Sciences, Engineering, Information Systems, or a related field
5 years of experience in: Quality Assurance, CSV, validation, or regulated IT environments
Strong demonstrated understanding of GxP regulations, 21 CFR Part 11, and Data integrity concepts (ALCOA+)
Ability to follow established procedures and quality standards
Strong written and verbal communication skills
Willingness to learn and grow under mentorship
Comfort working in regulated, documentation-heavy environments
Strong documentation, organization, and attention to detail skills
Collaborating with stakeholders to ensure the quality
Preferred
Experience supporting QA activities in cloud-based ERP environments (e.g., SAP)
Exposure to regulated systems such as LIMS, QMS, MES, and SaaS platforms
Experience working within Agile and/or Waterfall project methodologies
Hands-on experience using tools such as JIRA, HP ALM, Confluence, SharePoint, or similar documentation and test management platforms
Familiarity with: GAMP 5, Risk-based validation approaches
Company
Blue Marble Analytics
Founded during the transformative tech landscape of the early 2000s, Blue Marble Analytics emerged as a pioneer in providing strategic IT solutions.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase