Quality Assurance Specialist II

Standard BioTools•Boulder, CO

28d•$50,000 - $70,000•Onsite

About The Position

Would you like to join an innovative team driven by a bold vision – unleashing tools to accelerate breakthroughs in human health? Would you like to join an innovative team creating technology to power ground-breaking insights in academic, clinical, pharma and biotech research? It is an extraordinary time for Standard BioTools. Our technology is empowering customers to improve life through comprehensive health insight. We invite you to join a leading provider of indispensable life sciences tools that is accelerating global research on multiple frontiers of human health. At Standard BioTools, we are building a positive culture where our people can do the best work of their careers, informed and influenced by our core behaviors: Keep customers front and center in all of our work Be accountable and deliver on commitments Drive continuous improvement Be collaborative and work as one team: fostering communications in a learning, coaching, and helpful environment This position will report to the Manager, Quality Assurance and is responsible for completing onsite quality activities that support business operations, including product and material release. This position also supports other quality systems activities including customer complaints, CAPAs, supplier quality, nonconformances, training, document control, and audits. The individual in this role will be relied upon to ensure the compliance and effectiveness of the quality system for their role as defined in respective procedures.

Requirements

Bachelor’s or Associate’s degree in a Scientific or Technical field preferred but not required.
2-5 years in Quality or Operations, preferably within a related regulated field (pharma or medical device)
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
Ability to be on site 4-5 days a week

Nice To Haves

Desired experience with:
Electronic document management
Electronic Quality Management workflow
Change control systems
Good documentation practices

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