Quality Control Technician with Advanced Skills – VGXI

SUMMARY 

Responsible for assay assessment, development, implementation, and validation for use evaluating human biologic drug products manufactured in a cGMP environment. It is also the responsibility of this position to troubleshoot any problems that may arise and to be up-to-date on all methods applicable for QC testing. Set-up, organization, and day-to-day operations of a Quality Control Laboratory are also required.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

Responsible for QC assays as follows:        

  • Gel electrophoresis          
  • ELISA Assays
  • HPLC Analysis of Plasmid iso-forms                                 
  • qPCR Gene Expression and Genomic 
  • Mammalian Cell Culture and Transfection
  • Wet Chemistry Techniques

Responsible for Testing as follows:

  • In-process testing
  • Release testing
  • Stability testing

Responsible for Method Qualification and/or Validation

  • Qualification of USP/compendia methods
  • Tech transfer of assays
  • Test Method validation
  • Qualification of new equipment 

Responsible for documentation/administration as follows:

  • Organize all accumulated data
  • Keep notebook up to date and signed
  • Write Protocols for test method validation and Qualifications
  • Write development reports, validation and other relevant technical reports
  • Writing SOP’s, testing records and protocols

Responsible for QC analysis as follows:                                    

  • Spectramax software                                  
  • qPCR software     
  • HPLC software                              
  • Gel imaging software                          
  • Excel and word software                        

REQUIREMENTS:

  • Candidates should have a Bachelor’s or Associate’s degree and 3+ years of relevant experience and 2-5 years of assay development experience. 
  • Applicants must have a life sciences, molecular biology, microbiology or chemistry background. 
  • Experience with qPCR is a must. 
  • Experience with chromatography, gel electrophoresis and microbiology techniques are preferred. 
  • Method development and optimization experience in a cGMP environment is a plus.

Contract to hire position.

VGXI is an Equal Opportunity Employer.