On-Site
Full Time
Entry Level
Waltham, Massachusetts, United States
About Dash Bio
Our Mission:
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.
Company Summary:
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 at scale. We 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.
About the job
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.
Key Responsibilities
Site Quality
- Support day-to-day compliance activities at the Waltham facility, helping ensure 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 like 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.
Study Quality — QAU (GLP)
- Assist with Quality Assurance Unit functions for GLP-regulated nonclinical studies in accordance with 21 CFR Part 58, 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.
Qualifications
- Education: Bachelor's degree in a scientific discipline required (e.g., biology, chemistry, biochemistry, or related field).
- Experience: 1–6 years of experience in Quality Assurance, quality control, or a related regulated laboratory role. Prior exposure to GLP environments preferred; GCP exposure a plus.
- Regulatory Knowledge: Working familiarity with 21 CFR Part 58 (FDA GLP) and OECD Principles of GLP. Exposure to ICH E6 (GCP) is a plus but not required.
- QAU Exposure: Some experience supporting or observing QAU functions (study/phase inspections, facility inspections, report review) under GLP is preferred.
- Attention to Detail: Strong organizational skills and attention to detail, with the ability to manage multiple documentation and tracking tasks simultaneously.
- Communication: Solid written and verbal communication skills; comfortable documenting findings clearly and coordinating with lab and study staff.
- Systems Familiarity: Basic familiarity with document control systems, CAPA/deviation tracking tools, and general data integrity principles (ALCOA+) is a plus.
- Collaboration: Eagerness to learn from senior QA staff and grow into greater ownership of quality processes over time.
Benefits
Health Insurance
Dental Insurance
Vision Insurance
401(k) Matching
Paid Time Off (PTO)
Paid Holidays
Sick Leave
Preferred Skills
glp
qms
What We Offer:
- Opportunity to work at the forefront of bioanalytical innovation.
- Collaborative and inclusive company culture.
- Competitive salary and comprehensive benefits package.
- Direct access to industry veterans and a supportive environment for professional growth.