Quality Control Analyst II

Standard Biotools
Boulder CO
20 days ago
Standard Biotools
Standard Biotools
standardbio.com

Job Description

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
We are currently looking for a QC Analyst II to perform analytical testing of raw materials, finished product, stability samples, and R&D materials as part of the quality team. Additional requirements will include understanding the basics of proteomics and DNA, handing sensitive materials, performing statistical analysis on results, and technical writing to report results as part of supporting multiple departments to achieve a common goal.
Key Job Responsibilities:
  • Complying with cGMPs, CLIA regulations, SOPs, safety requirements, and all company policies and procedures
  • Take ownership of and responsibility for analytical testing, including method development or optimization as needed
  • Generating and maintaining laboratory data and records in accordance with company policies
  • Assist in designing product stability testing and writing testing protocol
  • Analytical analysis of material to determine molecular weight, purity, amount, and other parameters as required. Testing may be performed in support of multiple working groups
  • Independently perform and adequately document basic investigations for out-of-specification or out-of-trend results
  • Assisting or leading the execution / implementation of larger projects, including revising/improving test methods, SOP revisions, process improvement projects, etc.
  • Drive towards delivery of data and meeting deadlines, take ownership of associated tasks
  • As appropriate, will cross-train in other departments or job functions to meet production or assay timelines when needed
  • Participates in departmental or cross functional projects
Qualifications:
Education
Bachelor’s Degree – major in chemistry or related science is required
Skills and experience
  • 3 - 7 years of experience in a Quality Control work environment, preferably in the pharmaceutical or medical device industries, working under cGMP or ISO regulations required
  • Ability to test raw materials, in-process materials, and finished products
  • Experience with LC-MS, UPLC, spectroscopy, other instrumentation
  • Devise solutions for complex problems and execute to completion
  • Effectively prioritize and meet deadlines, ability to multi-task effectively
  • Learn to use new software as it relates to job function
  • Strong communication and presentation skills, including technical writing and reporting
  • Ability to build and maintain effective relationships across departments and working groups
  • Proficient in MS Office applications, highly proficient in Excel
Work Environment:
  • Ability to work in a fast-paced environment
  • As Somalogic is a Hazardous Waste Generator, this position performs hazardous waste duties in accordance with internal controlled documents, local, State and Federal regulations
  • Works in a laboratory setting. The individual will be required to enter production support areas and laboratories while wearing appropriate PPE (personal protective equipment) such as lab coat, gloves and safety glasses. Note: Potential to work in proximity to patient samples, including blood, plasma, CSF, and other matrices, including known and suspected infectious material.
Salary Expectations: $67,250 – 78,000

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