SomaLogic, Inc. Quality Control Analyst in Boulder, Colorado
SomaLogic is a privately-owned bio-information company that developed SomaScan®, a revolutionary proteomics platform technology capable of measuring thousands of different human proteins in a single small blood or other type sample. We are a dedicated team of cross functional professionals now moving towards commercializing the health-related information derived from our platform to help people worldwide proactively manage their health. As a part of our commercialization effort, we are seeking additional Quality Control expertise to join our dedicated team and help us realize that vision.
We are currently looking for a Quality Control Analyst to perform functional assays on raw materials, stability samples, and production materials as part of the overall quality team. This 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. Level commensurate with experience.
Key Job Responsibilities:
• Complying with cGMPs, CLIA regulations, SOPs, safety requirements, and all company policies
• Perform laboratory tests applied by the QC laboratory for evaluation of raw materials, components, and finished products
• Generating and maintaining laboratory data and records in accordance with company policies
• Conducting product stability testing and product expiration testing in accordance with defined schedules
• Participate in writing testing proposals, testing components to determine functional reliability, and creating final reports to document results
• Independently performing and adequately documenting basic investigations for out-of-specification or out-of-trend results
• Assisting department management in the execution / implementation of projects or other duties as required
• 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 process improvement programs or other projects
Bachelor’s Degree – major in biology, microbiology, or related science is preferred. Equivalent work experience will be considered.
Skills and experience
3 - 5 years of experience in a Quality Control work environment, preferably in the pharmaceutical or medical device industries, with knowledge of GMPs or ISO regulations required
Attention to detail required
Demonstrated ability to devise solutions for complex problems
Leverage underlying product/process knowledge to quickly assess changes, understand implications and determine solutions.
Ability to prioritize and meet deadlines, proven ability to multi-task effectively
Ability to build effective relationships across departments and working groups
Knowledge and experience using LIMS preferred
Strong communication and presentation skills, including technical writing and reporting
Experience in Spectroscopy and liquid handling robotics preferred
Proficient in MS Word and PowerPoint, highly proficient in Excel
Ability to work in a fast-paced environment.
Physical Demands / Surroundings – Works in a laboratory setting. The individual will be required to enter production support areas/laboratories while wearing appropriate PPE (personal protective equipment) such as lab coat, gloves and safety glasses. Note: Working in proximity to patient samples, including blood, plasma, CSF, and other matrices possible, including known and suspected infectious material.