Quality Assurance Jobs at Standard BioTools
Standard BioTools is seeking a Quality Assurance Specialist II to support essential onsite quality operations, product release, and continuous improvement initiatives. This full-time role is ideal for candidates with experience in regulated environments such as pharma or medical devices. If you’re detail-oriented, quality-driven, and passionate about advancing human health, this opportunity offers a chance to make a meaningful impact in a rapidly evolving life sciences company. Join for the Quality Assurance Jobs Now!
Job Details:
- Position: Quality Assurance Specialist II
- Location: Boulder, Colorado (On-Site)
- Job Type: Full-time
- Work Environment: Office + Occasional Lab Work (PPE required)
- Salary Range: $49,000 – $70,000 annually
- Requisition ID: 2025-0136
- Onsite Requirement: 4–5 days per week
About the Company:
Standard BioTools is a leading innovator in life sciences technology, empowering researchers to accelerate breakthroughs in academic, clinical, pharma, and biotech sectors. With a strong commitment to scientific excellence, the company fosters a collaborative culture built around continuous improvement, accountability, and customer focus. Employees are encouraged to grow, contribute, and take part in shaping the future of global health insights.
Educational Requirements:
-
Bachelor’s or Associate’s degree in a Scientific or Technical field (preferred but not mandatory)
Key Responsibilities of the QA Specialist Role:
- Attend standup meetings for manufacturing, QC, and lab teams
- Review and release incoming materials
- Oversee analytical QC (aQC) and functional QC (fQC) activities
- Review batch records and testing documentation for product release
- Maintain and review equipment maintenance and calibration records
- Monitor and approve nonconformance management
- File, track, and maintain quality record integrity
- Manage Change Orders and Quality events using eDMS/eQMS
- Create and revise documents, templates, and SOP-related content
- Support internal and external audits
- Handle customer complaints, CAPA activities, and supplier quality tasks
- Participate in continuous improvement projects
- Ensure compliance with regulatory requirements (21 CFR 820, ISO 13485, etc.)
- Perform hazardous waste duties per regulatory guidance
Skills Required for the QA Specialist Role:
- 2–5 years of experience in Quality or Operations (pharma/medical device preferred)
- Experience with electronic document management & quality systems
- Strong documentation and change control knowledge
- Understanding of FDA, ISO, CAP, CLIA regulations
- Excellent attention to detail
- Ability to multitask, prioritize, and meet deadlines
- Strong computer skills (Word, Excel, documentation tools)
- Ability to work independently following SOPs
- Strong verbal and written communication skills
How to Apply?
Applicants interested for the Quality Assurance Jobs must apply through the official Standard BioTools career portal. Make sure your resume highlights quality experience and familiarity with regulated environments.
