GLP QA Specialist - Bioanalysis & Compliance

About Us

Dash accelerates drug development. By fusing advanced automation-native lab workflows and integrated software into a unified platform, we provide the biopharma industry with the high‑velocity, high‑quality, data‑driven development solutions required to get life‑saving therapies to patients faster. Dash seeks to continuously improve industry KPIs and materially reduce the time and cost to bring a drug to market.

We are building the infrastructure for modern drug development. We are moving beyond the manual, fragmented processes of traditional service providers by taking a technology‑first approach to bioanalysis. Our platform is tech‑enabled, automated, and GLP‑compliant with the goal to industrialize the scientific workflows that act as bottlenecks in the industry. We deliver next‑generation preclinical and clinical bioanalysis results with unprecedented speed and precision.

We are a team of builders operating at the intersection of biology, hardware, and code. This is an environment for scientists and engineers who are tired of the status quo and are ready to apply their skills to solve hard problems  don't just run assays, we architect the systems that will define the future of drug development.

We are a place where employees are stretched to do the best work of their career. We are looking for engineers, scientists, and biotechnicians who want to make an impact on the world and leverage their skills in an innovative way.

Dash Bio is seeking a detail‑oriented and motivated Quality Assurance Specialist to support day‑to‑day quality operations across our site, laboratory systems, and GLP‑regulated study programs. This individual will execute core Quality Assurance Unit (QAU) tasks for bioanalytical studies under GLP (21 CFR Part 58, OECD Principles of GLP), assisting with inspections, documentation review, and quality system upkeep under the guidance of Quality leadership.

This is a hands‑on, execution‑focused role, ideal for someone early in their quality career who wants to build deep, practical GLP/GCP experience in a fast‑paced, technology‑first bioanalytical lab environment. The Specialist will work closely with the Director, Site Quality and senior QA staff to carry out routine site quality, lab systems, and study quality activities.

• Support day‑to‑day compliance activities at the Waltham facility, ensuring adherence to FDA, OECD, and applicable GLP regulatory requirements.
• Assist with Quality Management System (QMS) activities: document control, logging and tracking CAPAs, deviations, change controls, log books, training records, JDs/CVs, lab investigations, etc.
• Help prepare materials and documentation for regulatory inspections and client audits under the direction of Quality leadership.
• Compile site quality metrics and data for KPI tracking and Quality Management Review presentations.
• Conduct routine self‑inspections and walkthroughs of site and laboratory areas, and document findings for QA leadership review.
• Conduct routine review of Enterprise systems such as QMS, Environmental Monitoring, and CMMS to check for quality trends, environmental trends, and missed calibration/maintenance records.
• Review impact assessments of SaaS system changes and assist in documenting change control reviews.
• Support coordination with lab and IT teams to track qualification and validation status of systems supporting GLP studies.
• Assist with Quality Assurance Unit functions for GLP‑regulated non‑clinical studies, including scheduling and supporting phase inspections and facility inspections.
• Perform first‑pass reviews of GLP study plans (protocols), amendments, and final reports, flagging issues for senior QA review.
• Support the archivist in maintaining the study archive, master schedule, and archive access controls.
• Assist with quality checks of bioanalytical method validation and sample analysis documentation conducted under GLP.
• Help track and follow up on open QA findings, action items, and CAPAs related to specific studies.

• glp
• qms

• Health Insurance
• Vision Insurance
• 401(k) Matching
• Paid Time Off (PTO)
• Paid Holidays