Senior Quality Assurance Specialist

Blue 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. Established in the early 2000s, the company has evolved into a leading data and analytics firm committed to driving growth and innovation for its clients. Blue Marble Analytics specializes in areas such as data strategy, governance, advanced analytics, and business intelligence. With a tailored and client‑focused approach, the team ensures businesses can optimize their operations, improve experiences, and make informed decisions. Role Description The Quality Assurance (QA) Specialist supports Computer System Validation (CSV) and Quality Assurance activities for GxP‑regulated systems in the life sciences domain. This role works under the guidance of senior QA/CSV leadership to help ensure computerized systems are implemented, tested, documented, and maintained in a compliant and audit‑ready state. Candidate should be located in Indianapolis, IN area and willing to work on‑site a few days out of the business week. Responsibilities Support the development, review, and maintenance of validation documentation including, user requirements specifications (URS), functional requirements specifications (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 GAMP5 principles Support21CFRPart11 and Annex11 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 Required Qualifications 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, 21CFRPart11, 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 Qualifications 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: GAMP5, Risk‑based validation approaches Seniority level Mid‑Senior level Employment type Full‑time Job function Quality Assurance Industries Business Consulting and Services Referrals increase your chances of interviewing at Blue Marble Analytics by 2x Get notified about new Senior Quality Assurance Specialist jobs in Indianapolis, IN. #J-18808-Ljbffr