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Leucine is an AI platform transforming pharmaceutical manufacturing by replacing paper-based processes, Excel sheets, and tribal knowledge with software. The company serves 60+ pharma enterprises and is backed by top-tier global investors at Series A stage.
As a Product Operations Associate, you'll be the operational backbone of the product function, working alongside the Associate Product Manager. Your core responsibilities include:
**Testing & Quality Assurance**: Run structured functional test passes on new features before customer release, covering happy paths, edge cases, permissions, and error states. File actionable bugs with clear repro steps, expected vs. actual behavior, environment details, and severity levels. Verify fixes and execute regression testing ahead of each release.
**Test Case Development**: Translate PRDs and user stories into explicit test cases with preconditions, steps, and expected results. Maintain and version the test case library as modules evolve, ensuring the suite reflects current product state. Flag requirement gaps early—if a spec can't be tested, it isn't finished.
**Validation & Compliance Documentation**: Draft and maintain Computer System Validation (CSV) deliverables including user and functional requirement specs, traceability matrices, IQ/OQ/PQ protocols, and test scripts. Execute validation protocols and capture objective evidence (screenshots, logs, timestamps) to audit-ready standards. Compile validation packages, log deviations, and maintain alignment with 21 CFR Part 11, GxP, and ALCOA+ requirements.
**Product Documentation**: Write release notes, user guides, in-app help content, and configuration guides. Create internal enablement materials for sales, CS, and implementation teams. Produce meeting notes that become actionable items with clear ownership.
**Cross-functional Support**: Assist with backlog hygiene, competitor teardowns, feature research, demo environment setup, test data preparation, and data analysis to validate feature performance.
This role is ideal for someone who wants to learn product management through hands-on execution in a regulated domain. You'll see every feature up close, understand how software ships in a compliance-heavy environment, and build judgment that supports career growth into product management.
