Standard BioTools · 2 days ago
Quality Assurance Specialist II
Boulder, CO
Full-time
Onsite
Entry, Mid Level
$49K/yr - $70K/yr
2+ years expStandard BioTools is a leading provider of indispensable life sciences tools that is accelerating global research on multiple frontiers of human health. The Quality Assurance Specialist II will be responsible for completing onsite quality activities that support business operations, including product and material release, and ensuring compliance and effectiveness of the quality system.
BiotechnologyGeneticsLife Science
Responsibilities
Attend standup meetings for manufacturing, lab, and QC
Review and release of incoming materials
Review analytical QC (aQC) and functional QC (fQC) activities
Review testing and batch records associated with product release
Review Equipment Maintenance and Calibration Records
Monitor and approve non-conformance management steps
File and maintain integrity of quality records
Use electronic documentation systems (eDMS, eQMS) to process Change Orders and Quality events
Create, revise and drive release of documents and templates
Update databases and spreadsheets used to track, monitor, and report department activities
Support internal and external audit activities
Support quality issues and quality metrics related activities
Conduct assay study review and release to support laboratory services
Monitor and support development of training plans based on roles defined in procedures
Support Customer Complaints Program
Support CAPA Program
Support Supplier Quality Program by monitoring performance and managing Supplier Corrective Actions and supplier self-questionnaires
Participate in continuous improvement projects
Comply with applicable regulatory requirements, company policies, operating procedures, processes, and task assignments. (e.g. 42CFR493, 21CFR820, ISO 9001, ISO 13485, ISO 15189)
Other duties, as assigned
Qualification
Required
2-5 years in Quality or Operations, preferably within a related regulated field (pharma or medical device)
Ability to be on site 4-5 days a week
Work is in typical office environment and occasional work in a typical laboratory environment with personal protective equipment use required
The work environment may include, but is not limited to, the following hazards: chemical, electronic, mechanical, biohazard waste, and infectious materials
While performing the duties of this job, the employee is frequently required to stand and walk. The employee is regularly required to stoop, crouch, and twist
Occasionally the employee is required to kneel, squat, and sit
As Somalogic (now Standard BioTools) is a Hazardous Waste Generator, this position performs hazardous waste duties in accordance with internal controlled documents, local, State and Federal regulations
Preferred
Bachelor's or Associate's degree in a Scientific or Technical field preferred but not required
Desired experience with: Electronic document management, Electronic Quality Management workflow, Change control systems, Good documentation practices, Excellent attention to detail, Intermediate knowledge of FDA CDRH, ISO, CAP and/or CLIA regulations. (e.g. 42CFR493, 21CFR820, ISO 9001, ISO 13485, ISO 15189), Strong computer skills with word processing, spreadsheets, and software tools in support of preparing technical documentation and metrics, Ability to work independently while following Standard Operating Procedures (SOPs), Strong verbal and written communications, Multitasks, prioritizes and meets deadlines in timely manner, Attention to detail in preparation of materials and their review
Company
Standard BioTools
Standard BioTools is a biotech tools company that creates microfluidic-based chips and instrumentation for biological research.
501-1000 employees
H1B Sponsorship
Standard BioTools has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2023 (3)
Funding
Current Stage
Public CompanyTotal Funding
$435.2MKey Investors
Casdin CapitalLehman Holdings
2022-01-24Post Ipo Equity· $250M
2012-08-21Post Ipo Equity· $60M
2011-02-10IPO
Leadership Team
E
Emi Zychlinsky
Sr. VP of Quality and Regulatory
Betsy Jensen
Chief Human Resources Officer
Recent News
2026-01-09
2026-01-09
Company data provided by crunchbase