Quality Assurance Specialist II

Would you like to join an innovative team driven by a bold vision – unleashing tools to accelerate breakthroughs in human health? We are at Standard Bio Tools
, a leading provider of indispensable life sciences tools that is accelerating global research on multiple frontiers of human health. This is an extraordinary time to join our team.

At Standard Bio Tools, we are building a positive culture where our people can do the best work of their careers. Our core behaviors include:
Keep customers front and center
, Be accountable and deliver on commitments
, Drive continuous improvement
, and Be collaborative, 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. It also supports other quality systems activities such as customer complaints, CAPAs, supplier quality, nonconformances, training, document control, and audits.

• 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. 42
  
  CFR
  493, 21
  
  CFR
  820, ISO 9001, ISO 13485, ISO 15189)
• Other duties, as assigned

Education: Bachelor’s or Associate’s degree in a Scientific or Technical field preferred but not required.

Skills and Experience: 2-5 years in Quality or Operations, preferably within a related regulated field (pharma or medical device).

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. 42
  
  CFR
  493, 21
  
  CFR
  820, 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
• 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 Bio Tools) is a Hazardous Waste Generator, this position performs hazardous waste duties in accordance with internal controlled documents, local, State and Federal regulations

Salary Expectations: $50,000 - $70,000

Range for Role: $49,000.00-$70,000.00

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.