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QC Operations Specialist II

San Diego, CA

Your next role as a Miracle Maker 

Maravai LifeSciences is seeking a #MiracleMaker to join our Quality Control team as a QC Operations Specialist I. As a QC Operations Specialist II, you will be responsible for providing testing and technical oversight in Method Development, Qualification, Validation/Verification of QC test methods related to incoming raw materials, in-process materials, and final manufactured products. This successful candidate will thrive in a flexible fast-paced environment and demonstrated excellent attention to detail.

How you will make an impact: 

  • Routinely operate analytical (U)HPLC, mass spectrometer, , Gas Chromatography, pH/conductivity meter, TOC Analyzer, Viable and Non-Viable Air sampler, qPCR, dot blot, UV-vis spectrometer, FTIR, Fragment Analyzer, and restriction digests. 
  • Generates and executes method qualification/validation protocols.  
  • Troubleshoots routine equipment issues within the laboratory 
  • Is a technical subject matter expert on a variety of analytical instrumentation (i.e. UHPLC, mass spectrometer, pH/conductivity meter, qPCR, dot blot, UV-vis spectrometer, FTIR, Fragment Analyzer, TOC, EndoToxin Analyzer) 
  • Ensures that all product specifications are met and follows proper procedures for out-of-specification (OOS) results and reporting of non-conforming materials. 
  • Conducts investigations and provides first tier analysis of complaints and non-conforming products. 
  • Primary peer reviewer of testing data and write-ups of other technicians for accuracy and completeness. 
  • Serves as lead QC contact for communication to manufacturing and order fulfillment regarding testing schedule and product readiness. 
  • Trains and develops new team members on test methods. 
  • Serves as delegate for QC Management.  
  • Maintains meticulous documentation of all Quality Control records. 
  • Creation of QC standard operating procedures and optimizing new/existing analytical test methods. 
  • Assists with instrument calibrations and preventative maintenance.  
  • Maintains lab housekeeping, organization, and inventory supply. 
  • Performs other functions and duties as required. 

 The skills and experience that you will bring: 

  • B.S. or advanced degree in chemistry or biology or a related science or a minimum of 6-7 years of experience working in a laboratory, manufacturing, or quality role within the life science industry. 
  • Hands on experience with multiple of the following instrumentation: HPLC, Mass Spec, GC, qPCR, UV-Vis spectrophotometer, Fragment Analyzer, TOC Analyzer, Endotoxin Analyzer, Viable and Non-Viable Air samplers.    
  • Hands on experience in executing Method Development/Qualification/Validation/Verification activities.  
  • Familiar with USP<1225> Validation of Compendial Procedures and/or ICH Q2(R2) Validation of Analytical Procedures. 
  • Familiar with Chromatography Data Systems (i.e. Chromeleon).  
  • Computer skills (Database software, Microsoft Office Suite) 
  • Strong knowledge of and experience using GLP or cGMP principles.  
  • Working knowledge of standard chemical safety/hygiene requirements and overall safe workplace practices, especially in a laboratory setting. 
  • Ability to work independently with little to no supervision.  
  • Strong verbal and written communication skills. 
  • Strong interpersonal skills. 
  • Strong problem solving, observation skills, and attention to detail. 
  • Self-motivated and able to organize and prioritize multiple tasks. 

The anticipated salary range for this position is $76,246 - $85,988.  In addition, highly competitive long-term incentives in the form of company equity, bonus participation and company sponsored benefits are provided as part of the total compensation package.  The salary offer will depend on multiple factors which may include the successful candidate's skills, experience and other qualifications, as well as the location of the role.  

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