QA Specialist - GLP

About the Role

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.

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.

Requirements

• Bachelor's degree in a scientific discipline required (e.g., biology, chemistry, biochemistry, or related field).
• 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.
• 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.
• Some experience supporting or observing QAU functions (study/phase inspections, facility inspections, report review) under GLP is preferred.
• Strong organizational skills and attention to detail, with the ability to manage multiple documentation and tracking tasks simultaneously.
• Solid written and verbal communication skills; comfortable documenting findings clearly and coordinating with lab and study staff.
• Basic familiarity with document control systems, CAPA/deviation tracking tools, and general data integrity principles (ALCOA+) is a plus.
• Eagerness to learn from senior QA staff and grow into greater ownership of quality processes over time.

Benefits

• 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.