Product Operation Associate

We build software for pharmaceutical quality teams — the systems that decide whether a batch ships, whether an auditor walks away satisfied, and whether a deviation gets closed properly. That means every feature we release has to be correct, documented, and defensible to a regulator. Shipping fast and shipping validated are both non-negotiable, and that tension is exactly where this role lives.

You'll work alongside our Associate Product Manager as the operational backbone of the product function: testing what engineering builds, writing the test cases that define "done," producing the validation and CSV documentation our customers depend on, and keeping the paper trail clean while the product moves quickly.

This is not a role where you'll be told what to think about the roadmap on day one. It is a role where you'll see every feature up close, learn a regulated domain most PMs never touch, and build the judgment that makes a strong PM two years from now. If you want to learn product by being in the details of how it actually gets shipped, this is that seat.

Run structured functional test passes on new features before they reach customers — happy paths, edge cases, permissions, and the ugly states nobody designed for

File bugs that engineers can act on immediately: clear repro steps, expected vs. actual, environment, severity

Verify fixes and run regression sweeps ahead of each release so old bugs stay dead

Coordinate and support UAT with internal stakeholders and, occasionally, customers

Translate PRDs and user stories into test cases with explicit preconditions, steps, and expected results

Maintain and version the test case library as modules evolve — so the suite reflects the product as it is, not as it was two quarters ago

Flag gaps in requirements early: if a spec can't be turned into a test case, it isn't finished, and you'll be the one to say so

Draft and maintain Computer System Validation deliverables — 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 a standard that survives audit scrutiny

Compile executed validation packages, log and route deviations, and keep documentation aligned with 21 CFR Part 11, GxP, and ALCOA+ expectations

Work with engineering to keep validation artifacts in sync with what actually shipped

Release notes, user guides, in-app help content, and configuration guides

Internal enablement material so sales, CS, and implementation teams can speak to new functionality accurately

Meeting notes that become action items with owners, not notes that die in a doc

Backlog hygiene — grooming tickets, chasing missing detail, keeping the board honest

Competitor teardowns, feature research, and quick customer-facing artifacts

Demo environment setup and test data preparation

Pulling the data needed to answer "did this actually work?"

Exposure to pharma, biotech, medical devices, or any regulated environment — QA, QC, regulatory affairs, or validation experience is a strong plus

Familiarity with GxP, 21 CFR Part 11, GAMP 5, or CSV/CSA concepts

Hands-on QA or test-case-writing experience, manual or automated

Comfort with tools like JIRA/Linear, Notion/Confluence, Figma, Postman, or Playwright

Familiarity with AI-assisted tools (Claude, Cursor, and similar) to move faster on documentation and testing

Basic SQL or spreadsheet fluency for answering simple product questions